Inventory & Accounting ERP Software Blog

Why You Can’t Find Accounting ERP Pricing Online

Ever notice how it’s impossible to find pricing for accounting ERP software online? Have you ever filled out a “Request a Quote” form on a website expecting an email response, only to have a sales rep reach out to you by phone?

There is a specific reason why you can’t easily find pricing information online and that’s because the cost of accounting ERP software is complicated. Unlike introductory systems where information about different pricing options is readily available, true ERP systems are not a one-size-fits-all solution.  Therefore, the cost will depend on several factors such as the number of users, business processes, specific requirements and existing systems and infrastructure. For example, a company with multiple locations that sells through online sales channels is going to have different requirements than a company that distributes strictly through sales reps across a handful of states. Even if both companies are wholesale distributors selling consumer packaged goods, their requirements, processes and even the experience and knowledge of their employees will significantly vary, resulting in different software needs and costs.  For the most part, accounting ERP solutions for a specific industry (such as wholesale and distribution) will be able to address 70-80% of a business’ needs out-of-the-box.  However, most vendors competing in the small-medium size business space will also provide optional components that companies can turn on or off depending on its specific needs – at an additional cost.  A great example of this type of functionality is eCommerce. The ability to turn on or off built-in features is different from the ability to integrate with 3rd party applications, however, both typically involve additional costs.

Taking into account the above, it’s reasonable for an accounting ERP software vendor to need to speak with potential customers to gather information before being able to provide them with an idea of pricing. However, companies should never base the search for ERP software on costs alone. A good vendor will also take the time during phone discussions to learn more about a company’s specific requirements to first and foremost determine whether or not it would be a good fit – from a functionality and business culture standpoint. There are several other factors to consider which take priority over cost if you want to find the right solution for your business.

As the first step in searching for a new system, it is important to have a good understanding of your company’s processes and requirements as this will help vendors determine and make recommendations on key functionality. This information will help you and the vendor determine if their solution is the right fit and allow the vendor to provide you with an estimate of costs based on your unique needs.

Before you reach out to vendors to get pricing information, consider the following:

Industry/Functionality Requirements

Most true accounting ERP solutions will provide the same basic features for inventory management, order entry and processing, warehouse management, general ledger, accounts receivable and payable and contact management.  Therefore, it is important to consider other unique or industry specific requirements that will result in the need for certain functionality.  What are some things your business does that gives you a competitive advantage? Do you need specific functionality to address these processes? Are you looking to grow the business and therefore your needs will be changing in the next couple of months? It’s rare that any type of software will able to meet 100% of your unique business needs out-of-the-box, but most will be able to provide optional features or custom work.  As mentioned above, many ERP vendors provide optional components that a company can turn on or off to address specific needs, however, each of these will add to the cost of the system.  Keep in mind that ERP is designed to be scalable as your company grows, allowing you to add additional features down the road.

Number of Users

Many vendors base the cost of their software around the number of users or software licenses. However, there may be different ways of accessing information in an ERP solution and therefore the number of users required may change from what you currently have.  Some vendors also provide different pricing depending on the needs of the user or will have the same pricing with the ability to set different permissions and security settings for individual users or groups of users. The more information you can provide a vendor about who will be accessing the system, and what they will be doing, the more accurate pricing you will get. In general, the more users you have, the higher the costs.

Implementation

Trying to estimate and provide implementation costs is quite difficult for ERP projects, especially early on in discussions. The fact that some vendors provide set costs, while others charge by the hour, makes it even more difficult.  Data migration and training costs tend to impact overall implementation costs the most but will depend on several different factors such as:

Training

Are the same users going to be trained on multiple areas of the software?
Do employees have experience using modern software solutions, or will there be a large learning curve when implementing new technology?
Are employees willing to change and learn a new solution?
How many people need to be trained? Typically, the more people being trained, the more work is involved. It tends to be easier to train a group of 5 employees than a group of 20.

Data Migration

Is the data being moved from multiple systems and will it be in different formats?
Is there a lot of data clean-up required in terms of old or bad data, duplicate records, formatting issues?

On-Premises or Cloud

Another factor which affects costs is whether or not you decide to implement a cloud-based/hosted solution or on-premises. Some vendors will offer both options in which case they will be able to guide you through the process of choosing the right solution for your business.  From a cost standpoint, cloud-based solutions are subscription-based in that the vendor charges monthly license fees, whereas with on-premises all licenses are bought and paid for upfront. In addition, on-premises implementations require an up-to-date server and other hardware which can sometimes be an additional cost (and requires on-going maintenance from IT). With cloud-based solutions, hardware, server, and IT maintenance become the responsibility of the software vendor, with associated costs included in monthly fees.

As with any other large capital investment, implementing new software takes time and money – you wouldn’t purchase a new warehouse without first performing research and speaking with the appropriate people from your team and from the real estate industry.  Before you begin your search for new software, make sure you’re in the right mindset – the right system should be a strategic investment for your company and not just a necessary evil. More advanced accounting ERP software will be able to better handle an increase in order and transaction volume, manage orders from multiple sales channels, increase automation and reduce the amount of time needed to enter data, and allow employees to focus on more meaningful work and less on administrative tasks.  Set aside the time to have productive conversations with software vendors, as this will make the search and selection process easier.

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When to Involve Decision Makers in your Software Search

Searching for new inventory and accounting software to manage your business is a cumbersome task involving a lot of time, money and mental resources.  Between initial discovery calls with potential vendors, to more in-depth discussions, to multiple demonstrations, the search process can quickly become overwhelming for employees. This increases with the number of vendors you evaluate. Evaluating too many vendors can lead to information overload and hinder the search process by making it difficult to distinguish between the functionality, costs, and fit of each. Another factor that can hinder the search process is waiting too long to involve decision makers. Below we discuss why.

Project Manager

First and foremost, when making the decision to replace existing software systems, it is important that you assign a “project manager”. Ideally, this person understands business operations across all departments in order to speak to potential vendors about required functionality and specific processes. This person needs to be engaged in the search with visible support from management and ultimately the final decision maker(s).  Having someone take ownership of the project helps to ensure everyone involved stays on track and that it remains a priority. However, it is important that the search does not take time away from the project manager’s normal responsibilities or cause them additional stress. If the project manager is not dedicated to the search or does not have the bandwidth available to find a new system, it will impede the results.

Who to Involve and When

To find the right solution, it is important to create a list of potential vendors by doing preliminary research and then scheduling initial discussions with those who make the short-list. This initial conversation will act as a starting point for discussing scope, needs, fit, budget etc. at a high level only. It is important to use these initial conversations to narrow down your list of vendors for further discussions and demonstrations. At this stage in the process, it is enough to only involve the project manager, assuming they have all the information they need from management and the rest of the team – in terms of must-have requirements, an understanding of processes and an appropriate budget. After these initial discussions and when the list of vendors has been narrowed down, it is appropriate to begin scheduling more in-depth discussions.

It is during this first set of more in-depth discussions that you will want to involve decision makers and other members of your team, even if they do not participate in the entire conversation. The danger in waiting too long is that it can result in your evaluation criteria changing and the duplication of work.

Evaluation Criteria

Unless your team and the decision makers have had multiple in-depth internal discussions, it is likely that there are certain priorities and concerns around the software search that you will miss. What is important to the controller at a company from a functionality standpoint is not going to be the same as what is important to the warehouse manager, sales manager or owner. Therefore, it is essential to involve people from different departments not only when creating priorities for the software search, but also during discussions with vendors. This reduces the risk of missing certain features and of the evaluation criteria changing. It also makes it easy for each department to ask their own questions around specific requirements.

Duplication of Work

The second risk of waiting too long to involve decision makers and other people from your team is the duplication of work. There is no point in the project manager sitting through detailed discussions or participating in a live demo if the decision makers or other people from the company want to participate as well. What often happens is that the project manager goes through the process, and then as soon as it comes time to sign off on a proposal, decision makers and management worry that aspects of the search have been missed and insist on revisiting conversations and demos with vendors. To avoid this issue and the duplication of work, involve other members of your team as soon as possible.

 

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Blue Link Launches First Controlled Substance Ordering System (CSOS) Sold as Part of ERP Solution

We’re thrilled to announce that Blue Link now offers a Controlled Substance Ordering System (CSOS) component as part of our integrated inventory and accounting ERP software! Blue Link ERP CSOS eliminates the need for pharmaceutical distributors to acquire third party CSOS.

VAUGHAN, Ont. – April 6, 2017 – Blue Link Associates offers a CSOS component as part of its Blue Link ERP pharmaceutical software. Certified by Drummond Group, in accordance with the US Department of Justice Drug Enforcement Administration (DEA) Code, the Blue Link ERP CSOS component completes the suite of functionality requested by pharmaceutical wholesale distributors selling controlled substances in the pharmaceutical industry.

Industry regulation states that when a customer purchases Schedule II controlled substances, they must complete a DEA 222 Form and mail or courier the signed original to the distributor. According to DEA statistics, the typical turnaround time between trading partners when purchasing Schedule II products without CSOS is 1 to 3 days from the time a customer submits an order until it is either picked up and delivered or couriered. If the customer places the order through regular mail, the turnaround increases to 3-7 days. The cost of couriers, errors on the form etc. all contribute to added costs for pharmaceutical trading partners.

The use of Blue Link ERP CSOS allows users to accelerate this process and minimize time-consuming errors. A customer can log into the secure Blue Link B2B Online Ordering System and create a sales order. If the customer adds a Schedule II item to the order, they then select their digital certificate and “sign” it using their encrypted password. The whole process takes minutes, not days, with no errors, paperwork or costs for couriers. Blue Link ERP software then receives the order directly from the Online Ordering System for further processing and shipping.

“The Blue Link ERP Controlled Substance Ordering System is an exciting innovation for pharmaceutical distributors”, says Darren Myher, Blue Link’s Vice President of Operations and Development. “For the first time, pharmaceutical distributors get DEA certified CSOS functionality as part of an all-in-one ERP solution.  This gives them a competitive edge by allowing them to serve their customers quicker and more efficiently.”

About Blue Link Associates: Blue Link ERP provides small to medium size wholesalers and distributors an integrated accounting and inventory management ERP software. The pharmaceutical functionality Blue Link offers helps pharmaceutical wholesale distributors comply with existing DEA, FDA and DSCSA requirements and aids them in becoming VAWD accredited. With the inception of the Blue Link ERP Controlled Substance Ordering System (CSOS), pharmaceutical distributors have the means to offer their customers the ability to place a sales order, including for Schedule II controlled substances, on-line, using an integrated, all-in-one DEA certified solution.

 

 

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Distribution ERP Software – When to Customize, When to Configure?

From dress shirts to gifts, and even houses and cars…customized and personalized goods are certainly prevalent with customers who desire to have unique products.  Consumers can choose from a range of variable options- colors, text, sizes, material etc. But in the world of technology, specifically, Distribution ERP Software, is customization worth all the hype?

Before we can explore the value and benefits of customization, it is important to understand the term configuration. You may have heard this term during software discussions with vendors but what exactly does it mean and how does it differ from customization?  Understanding the differences and benefits between the two terms is crucial to determining if customization is necessary and can lead to significant cost and time saving, plus, having the most recent and updated version of the software.

Configuration

With any true distribution ERP software, you have the ability to configure the system to your business. This means that you can set-up the system for a designated task. Frequently, configuration can address 75-80 percent of your process needs without requiring any changes to the source code. Some examples of configuration include: setting up bank accounts and net receivable times, setting UDF values and notifications, creating user permissions, sales reps/commissions etc.

Customization

Customization entails modifying or adding features to a particular system to adhere to specific tasks. So, if a business decides to add on or modify features outside of the 75-80 percent of adaptable features through configuration, this is where custom work comes into play.  Unlike configuration, customization typically involves making development changes to the system’s source code.

Which is the best for your business needs?

All-in-one distribution ERP software has evolved significantly over the years resulting in fewer and fewer organizations having to do custom work or compromise on functionality. However, keep in mind it’s very unlikely that you find a solution that caters to 100 percent of your unique business processes and needs. Therefore, if you come across distribution software that can handle 80 percent or more of your business with configuration, you’re in luck!

Not only is this a cost-conscious solution compared with a full-blown custom job, but it also means easier system maintenance. When a vendor releases an update, the migration process is fairly seamless for software that doesn’t have much or no custom work done. Whereas custom work requires more labor and time to implement an upgrade. Many businesses often opt-out of upgrades altogether due to associated costs and time and end up with outdated systems.  Timeframe also plays a big part when it comes to implementation and upgrades. The more custom work you have done, the longer it takes to make changes.

This is not to say that a company should never customize their software, however, one should ensure that the custom work is able to deliver realistic and tangible value to your business.  You should also make sure that you check with the software vendor to determine how customization affects upgrades. Some vendors automatically include all customization work in each version upgrade at no additional cost, whereas others will charge significant fees for upgrading customizations. With the latter, understand that you are making a very expensive decision when you take into account the amount you will have to pay every time an upgrade is released.

Optional components or modules can be a good solution to additional needs such as advanced inventory tracking and reporting features. Optional features that have been tried and tested and have proven to have brought significant value to businesses may be worth considering. Since it’s just a matter of the vendor turning on or off these optional components, there is minimal risk involved when it comes to upgrades or the features working correctly. Examples of such features include CRM, Point of Sale, Sales/Budget Estimates and Tax integration to name a few.

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From Order to Invoice: Managing Workflows with Wholesale Software

Every wholesale company will have their own process for managing orders, receiving inventory, picking, packing and shipping product and then invoicing customers. How a company manages these workflows will depend on which sales channels they use, how their company infrastructure is set-up and what systems they have in place to automate and manage each process.  This is where back-end inventory and accounting wholesale software comes into play.  Since most wholesale and distribution businesses operate in a similar manner, proper software will have functionality in place to streamline the order entry process, automating as many steps as possible.  If you’re only familiar with introductory software for managing workflows, it’s difficult to visualize how proper wholesale software will increase efficiencies and manage processes.  This functionality is standard in most sophisticated inventory and accounting (ERP solutions), with small differences and available features depending on the vendor.  Below we take a look at a sample workflow:

Sales Orders

A customer places an order for product from your company.  This order can come through a variety of sales channels including electronically through eCommerce and EDI, via a tablet app from sales reps at a trade show, as well as over the phone or in-person. If you process a lot of volume through eCommerce, there are several options for automating the order, inventory and shipping information that flows between your eCommerce site and back-end wholesale system.  Whatever the method, this action triggers the beginning of a more complex workflow. The system accumulates all sales orders in a review screen for further processing and allocates inventory towards each order. Previously defined system parameters allow users to visually see which orders are ready to ship, and which require further review depending on customer account information and available inventory. When placing orders online, customers have access to product information and availability.  This information is also readily available when manually entering a sales order into the system while speaking with a customer over the phone or in-person. If inventory is not available, employees can place items on backorder. If applicable, customers can also submit credit card information online or over the phone and the system will pre-authorize the information before finalizing the order.  The sales order review screen provides a place to review orders before they continue to move through the workflow.

Purchasing

If there is not enough inventory available to fulfill an order, users can create a purchase order directly from within the sales order screen. System parameters allow companies to set up a default or preferred vendor for each inventory item, with the ability to see all available vendors. To avoid creating frequent backorders, re-order levels are set-up within the system to automatically notify the appropriate person when stock levels need replenishing. Submission of a purchase order is purposefully a manual process even if re-order levels are set – this ensures that employees can confirm order information and review purchase orders in case specific pricing discounts are available before sending to the supplier.

Receiving

There are several different options for receiving inventory into your warehouse upon delivery of a product.  The first involves manual methods of counting items and entering them into your system.  The second involves importing information into the system from an Excel spreadsheet and then checking against physical inventory. Lastly, employees can scan inventory items into the system with barcode scanning and product quantities will update automatically. If necessary, users can then manually override this information. When receiving items as part of a backorder, if the corresponding purchase order is associated with a sales order, the system will automatically allocate product to the order for quicker order fulfillment.

Picking, Packing and Shipping

If inventory is available to fill orders, the system generates a pick slip so that warehouse staff can begin picking items.  This can be done manually, following a process in which staff pick items from shelves following a logical pick order according to the bin and shelf location on the pick sheet.  Employees then put items on a cart and bring the cart to a packing station where they check items against the sales order and pack accordingly.  Alternatively, employees can use verification barcode scanning at the packing station or mobile barcode scanning during the pick process as a means to double check against the sales order. Once the employee packs the items, the system will generate and print any required paperwork and share information electronically between shipping carriers in order to generate a tracking number and cost information.

Invoicing

When it comes to invoicing, the level of automation will depend on a business’ specific processes.  Once an employee ships the order and dictates as such in the system, common workflows include:

Automatically posting the invoice, changing the status and emailing the invoice to the customer, or
Automatically changing the status, which then allows employees to manually review all shipped orders and invoice customers

When it comes to managing workflows, most wholesale distribution businesses will require similar functionality.  As such, sophisticated inventory and accounting wholesale software that is designed to replace introductory systems will provide features to help automate processes and streamline the order entry, picking, packing, shipping and invoicing process. When working with potential software vendors, be open to the expert advice they will have to offer when it comes to managing workflows.  With proper back-end software comes an increase in available functionality as well as opportunities to improve existing processes.

 

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Missed Dx3 Canada 2017? Here’s a Recap

2 days, 50 speakers, 5 interactive labs, 100 exhibitors and thousands of attendees-  Dx3 was yet again a mecca for the best and the brightest in the Canadian digital space.  Attendees and exhibitors gathered downtown Toronto to learn from industry experts and interact with the latest technology that’s shaping behaviors across the marketplace.

While we noticed that the show floor held fewer exhibitors than last year, it was still an exciting showroom at the Metro Toronto Convention Centre on March 8-9. The venue buzzed with tremendous opportunities for established and upcoming businesses to network and collaborate. PayPal once again hosted The Startup Zone showcasing the innovative startups making waves in Canada. There was also a Canadian Retail Innovation Challenge- a national competition to help discover and promote the best retail and technology entrepreneurs that Canada has to offer. The winner this year? StyleID – the makers of an app that let you purchase items you see on your favorite TV shows. Tech journalist and TV personality, Amber Mac was also on-site, interviewing and live streaming discussions with numerous exhibitors including Blue Link’s own CTO, Darren Myher!

Among the excitement, we noticed a prevalent theme at the show- how technology is changing the consumer experience. All things virtual reality reigned supreme with a focus on how VR devices will reshape retail by creating interactive experiences. There was a big push for the importance of businesses to invest in technology to offer this type of buying. While we can’t argue that VR devices certainly take the consumer experience to a new level, does it actually impact purchasing decisions? Is it worth the hype? And, which industries can benefit the most? One of the greatest things about Dx3 is that it allows attendees to ask these types of tough questions. While it’s hard to say at this point whether or not VR will have the impact on the industry a lot of companies are hoping for, it was certainly interesting to be able to experience the technology first hand.

If you’ve never been to Dx3 before, we highly recommend you attend next year’s show. It really is a one-stop-shop to learn, speak and interact with multiple vendors and technology companies relevant to both B2B facing and B2C organizations, as well as the end-consumer.  Aside from floor exhibitors, Dx3 also provides a plethora of learning opportunities through their speaker sessions (at an additional cost).  This year, almost every session was full and the free open-air theater sessions as part of the show floor were standing room only.  Attendees walked away with some invaluable information and ideas that they can easily implement into their own businesses. Topics included:

Why We Buy: Behaviour is the Science presented by Estee Lauder Companies
How to Build Loyalty: Think Like a ShopKeeper presented by DavidsTea
How to Combine the Online and In-Store Shopping Experience presented by Kit Ace

Oh and did we mention, early bird floor passes are free!? If we still haven’t convinced you about the benefits of attending Dx3, be sure to check out their website to see all the highlights from this years show!

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7 Revealing Questions To Ask Warehouse Inventory Software Vendors

When it comes to Warehouse Inventory Software, there are commonly asked questions that our Sales Team addresses on a frequent basis:
“What is the cost of the software?”
“How long will it take to implement?”
“Who is responsible for the implementation?”
Although these are all valid and important questions to be addressed, other not-so-obvious yet equally significant inquiries need to be discussed to save yourself the hardships of an implementation war.  Keep in mind that a good software vendor will also ask you a variety of questions to ensure that their system is a good fit for your unique needs.

Here are our top 7 revealing questions to ask Warehouse Inventory Software vendors.

1)      What functionality do you have that is especially useful to my industry?

Choosing the right warehouse inventory software is a cumbersome task for any company, but can get even more complicated when industry specific functionality is needed. For example, certain industries such as Apparel, Food and Beverage and Pharmaceutical and Medical all require specific features in order to comply with regulations and manage processes.

So, when you evaluate vendors, be sure to ask what capabilities they have that are a must-have for your industry. Some unique features include:

Lot tracking 
Landed cost tracking 
Pharmaceutical license tracking
Product matrix

2)      How do you consistently provide ongoing innovation and value?

You want to make sure that your investment is not short-term and that your warehouse inventory software will still be functional and useful to your business years from now. This question will help you determine if the company is capable of keeping up with changes in technology, regulations, and business processes. How often do they release updates? How are they staying on top of industry compliance? The last thing you want to do is sign on with a company that is stagnant in their development and cannot keep up with your company’s growth.

3)      Who is your software not a good fit for?

This question is good for filtering out any shortcomings early in the buying process.  A good vendor will also recognize if your needs are outside the scope of what they can deliver and will let you know ahead of time. There are certain deal-breakers when it comes to determining if warehouse inventory software is the right fit for your business- budget, industry-specific functionality, implementation timeframe, language requirements, multiple currency requirements etc. Take the time to thoroughly analyze your business processes to identify any outside-the-box or unique features that you require before you speak with vendors.

 4)      What are your service offerings beyond functionality?

It’s easy to get caught up in the specific functionality a vendor can offer you but what about the kinds of services they offer you beyond the software itself? Some services include:

Data Migration- Can they migrate all relevant data from older systems without the need for manual data input?
Training- Do they have a qualified team that can teach your employees how to best utilize the system?
Customization- Some vendors offer customization to ensure that the most unique aspects of your business are implemented
Technical Support – Do they have an in-house support team? What are their hours of operation and how quickly can they respond to your needs?

5)      How often will you meet with me to discuss my system?

This is a question that rarely gets asked leading many businesses to miss out on some great opportunities. Depending on the vendor, you’ll be able to set up one-on-one meetings to go over any concerns and needs you may have on a frequent basis. Take advantage of these sessions as they are normally a part of your service package. It’s a great way to stay on top of the software and ensure you’re using it to its fullest capability.

6)      What kinds of companies are in your customer base?

Knowing that the vendor has successfully implemented other companies in your industry is a good sign that they are able to deliver a smooth implementation for your business. Ask them if they have testimonials or high-level examples of the types of warehouse inventory processes and regulations they are able to support that are relevant to your business.

7)      Can you give me industry references?

Always ask for references. Talking to current customers in your industry gives you greater confidence that the software can and will perform as promised. This is usually done at the later stages of the buying process. Be sure to ask the references what went right, what went wrong and what they would have done differently. If the vendor can provide you with at least two references in your industry, chances are they have the experience you require.

 

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B2B eCommerce in the Age of B2C eCommerce

Alright, we get it – B2C eCommerce is a must these days to remain competitive in the marketplace.  But what about B2B eCommerce?

More and more wholesale distribution businesses are implementing B2B eCommerce sites – also known as online order portals – to give their customers and sales reps access to inventory and pricing information and to allow them to place orders 24/7.

Unlike B2C eCommerce though, the majority of B2B businesses are not online ordering product at 2 am.  Instead, the benefits of access to online shopping are that it provides businesses another sales channel for customers to order through – giving customers more ownership of the ordering process without the need to hire additional staff to manage the channel in-house.  It also makes sense for companies where employees and sales reps travel frequently, work from home or remote offices and need the ability to place orders on the road or at tradeshows.

For B2B websites, the site can be set-up to act as a business’s primary and only website. Information about the company is displayed across a variety of pages, however, the main difference with B2B eCommerce is that visitors must first create an account to access certain information online and actually place an order. A business can choose to allow visitors to browse product with or without a login.

Alternatively, B2B eCommerce can be set-up where the company already has an existing website in place. In this situation, the online order portal hides behind a login link that is a part of the main website’s infrastructure. In some cases, this option is best as it allows a business to sell both B2C and B2B – where the former does not require a visitor to already have an account set up with the company.

Whichever way a company sets up their B2B and B2C eCommerce sites, it’s important that both fully integrate with back-end inventory and accounting systems for inventory management and order processing. This ensures inventory information such as quantities, pricing, descriptions, and images, as well as account and shipping information is accurate and up-to-date across all sales channels.

Other important differentiators between B2B and B2C eCommerce stem from the unique processes of each business model. A typical B2B site focuses the experience on managing relationships with existing customers.  Visitors can login online to view a personalized eCommerce site where customer specific pricing, inventory, past sales orders and statements are available.  Customers will have an existing relationship with the vendor and therefore will have negotiated specific pricing and terms.  With B2C sites, pricing and inventory information tend to be the same for all customers, and new visitors can easily place orders.  With B2C eCommerce it is imperative that customers know what product is available online and visitors expect their order to ship soon after it has been placed. With B2B on the other hand, this process is not as important.  From a business standpoint, there are differing opinions on whether or not to show available inventory at all and the compromise is to show available or not – as opposed to an actual count of items.  This allows a business to fulfill orders for customers based on priority, as opposed to when the order was actually placed. In addition, creating a backorder for items not on hand is much more acceptable and even expected with B2B orders – where you have a relationship with the supplier and have negotiated a good price.  With B2C if a consumer cannot find what they are looking for from your website, there is a good chance they can order from another company just as easily.

As more and more B2B businesses start to sell product online, features previously only associated with B2C eCommerce are becoming available.  Examples include:

The ability to find a retailer near you.  This feature gives visitors the option to pick up product from a nearby store location or alternatively visit the store to see the product in person before deciding to purchase. It also helps businesses make decisions about what inventory to stock based on who else is selling it in their area.

Customer specific accounts.  For B2C eCommerce, new visitors can easily create an account to purchase product and some sites allow visitors to purchase as a guest. If a visitor creates an account, this experience can then be personalized to the visitor to show them product they may be interested in based on past orders, or new items available.  This also provides sites the opportunity to offer discounts and promotions.  With B2B eCommerce, since each customer will already have their own account set-up, the information they see can also be customized to meet their needs. Aside from customer specific pricing, statements and inventory, B2B sites can also suggest new products, show discounts, and promotions and make recommendations based on past orders.

Other features include:

Shopping lists
Promotional lists
Search by brand/vendor/category
Ability to highlight “new” products under each category/brand/vendor
Image gallery – can show multiple images per item

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Dx3 Canada Invites You To Speak With Leading eCommerce Innovators

For many (if not all) businesses today, the opportunities created by advancements in the digital and tech world are ever growing and ever changing. There are endless possibilities to increase revenues and cut costs with new technologies and the ability to integrate them seamlessly into business processes. But, with this evolution comes tremendous pressure to stay on top of the latest and greatest technology and digital solutions to remain competitive in today’s market.

Well, Dx3 Canada is the perfect opportunity to immerse yourself in an educational experience that is centered on the changing world of digital, technology, data, marketing, and retail- all in one place!  Whether your business is continuously adopting new technologies or you’re simply just curious and not sure how to navigate the unfamiliar digital realm – Dx3 is the place to act for tomorrow.
Dx3-Canada’s Leading Technology, Digital, Marketing and Retail Event
Date: March 8-9, 2017
Place: Metro Toronto Convention Center, Toronto
Booth: Blue Link will be welcoming you at booth #316 and will be pleased to discuss the back-end challenges of eCommerce.
 

Here’s why you should attend:

1. Network with like-minded professionals

Dx3 is certainly not your average trade show. Now in its sixth year, the show has created a unique space and has a little something for everyone, encompassing all things digital- eCommerce, marketing, advertising, publishing, retail, and customer interaction. Over 130 exhibitors are on deck to learn from, and 52% of the audience is director level or higher. But, it’s so much more than that. The show creates a community-like feeling, which cultivates useful partnerships that exist well beyond the two days at the show.

2. Get your hands on the latest technology 

Dx3 is highly interactive- you can get your hands on the latest technology that is responsible for changing our industries and shaping consumer behaviors…why not have a bit of fun learning!  This year’s show will have play zones that include an interactive VR Lab, Agile Retail Lab, PayPal Startup Zone, and so much more.

3. Gain valuable information you can implement into your business now

The show will also boast an impressive list of speakers including Philippe Lozier (Vice President, Content and Services at Samsung), David Allard (VP, Integrated Marketing Communications at Coca-Cola), as well as speakers from Walmart, American Express, BMO and much more.

Expect to learn about:

  How digital is shaping the future of physical retail
 Why ‘Digital Experience’ is the new customer experience
  How to use real-time data to solve real-time problems
How to turn first-time visitors into customers

4. Free floor access

That’s right. Floor pass tickets are absolutely free until February 24th. All you have to do is register. So what have you got to lose?

Oh yea, and Blue Link will be there and we’ll be talking back-end eCommerce processes!

Having experienced the energy and innovation at last year’s event, we’re thrilled to be able to exhibit again this year! Drop by Booth #316 where we’ll be discussing how to adopt back-end eCommerce software to manage your growing online business.

By now, most businesses whether you’re a wholesaler, distributor or an importer and exporter, are all well aware of the value of selling through multiple sales channels, especially eCommerce –B2B or B2C. The online retail space is continuing to grow at an exponential rate, and that means new competitors setting up shop every day. While it seems quite simple to just set up a Shopify or Amazon site and leave it at that…we’ll be discussing why you shouldn’t.

We’ll be asking questions to determine if a back-end eCommerce solution is the right fit for your business. Questions like, How will orders get fulfilled? How will you manage your warehouses and inventory to process orders as quickly and as accurately as possible? What happens to an order right after it is placed online? Visit our booth to learn about the importance of having robust software to handle back-end activity of order fulfillment processes.  For your benefit, we will also have our ERP integration service provider, Virtual Logistics onsite to discuss how the integration of an ERP solution into your business works.  Another bonus? eCommerce channels and platforms such as Shopify and Demac Media will be steps away from our booth if you want to dive deeper into your eCommerce integration options. 

For more information on Dx3, visit their website or register today! Floor passes are FREE until February 24th but we encourage you to grab an All Access Pass for entry to the speaking sessions as well.

 

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4 Important Apparel ERP Software Functions That Boost Productivity

Running an apparel business isn’t easy. From sourcing to sales, to managing warehouses to distribution- there are numerous operational complexities involved, especially when it comes to inventory.  A single piece, whether it’s a shirt or a shoe, can have countless variations such as color, size, and style and need to be tracked individually. It’s no wonder that inventory solutions are a top priority for most in the industry when evaluating apparel ERP software.

However, there are several other features and benefits that often get overlooked and many businesses are simply unaware of their options. Keep in mind that a good software vendor is one who spends the time with you to identify any unique requirements and make recommendations on functionality that can benefit your business. This is why finding a vendor with industry experience is beneficial. Some of the features important to those in the apparel industry include:

Apparel Matrix

An apparel matrix greatly simplifies order entry and purchasing by allowing users to enter quantities in a matrix format with different product variations such as color, style, size etc. It also offers easy viewing of product availability within the system which comes with its’ own advantages. For example, let’s say a customer wants to place an order for 20 green shirts in size small- you can easily look up the availability of the exact item in the system and determine if you can fulfill the order immediately or if the product needs to be backordered. Matrix functionality allows users to enter, edit and manage inventory items without the need to enter items line by line.

Digital Document Management

Many businesses are still manually entering information from important documents into their inventory and accounting system. In today’s market, automating processes is key to boosting productivity and staying competitive. Fewer manual processes mean faster operations and reduced errors.  Implementing a back-end system with digital document management provides many benefits to those in the apparel industry, including:

The ability to easily store, index and retrieve documents such as design prototypes and logo images

Useful when on the phone with customers or reviewing multiple design options

The ability to keep important and confidential information safe by storing it electronically instead of in paper format
Eliminates the need for physical storage space

Transformational Purchase Orders

A transformational purchase order is when one existing inventory item is transformed, through the use of a third party vendor, into one or more different items. In the apparel industry, this includes a third party vendor adding logos, graphics, embroidery, or other design elements that change the original piece of inventory. When using transformational purchase orders, transformed items have the cost of both the original root product as well as the incremental processing cost of the 3rd party vendor.  In multi-step transformations using multiple vendors, new purchase orders and drop ship information are automatically created.  The system automatically creates payables for the incremental costs and transformation purchase orders can also tear apart assembled inventory.

Customer Relationship Management

Integrated Customer Relationship Management functionaliy means there is a single point of entry for all supplier/vendor and customer information in terms of names and address information- without the need to track and maintain relationships in standalone systems or in Excel. When searching for CRM functionality, find a system that allows you to:

Create quick quotes for prospective and existing customers and then convert quote to sales order upon approval
Create contract pricing rules (price lists for specific customers based on negotiated prices and terms)
Log verbal and email communications for prospects, suppliers, and customers

One of the biggest benefits of acquiring apparel ERP software is that the system is designed to manage business processes from end-to-end.  Information is maintained by a single data-base so that data is accurate across all sales channels and departments.  Users do not have to enter information into multiple systems or worry about information not being up-to-date.

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How to Manage DSCSA Requirements with Pharmaceutical Software

This post is Part 6 and the last post of the Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies. To read the first 5 parts of the Series, visit the links at the end of this post.  

In November 2013, former President Obama signed into law the “Drug Supply Chain Security Act (DSCSA)”. For the past few weeks, we’ve reviewed the information included in the DSCSA and discussed the most applicable requirements that impact pharmaceutical wholesale distributors and their ability to comply with the outlined regulations. In this final post of the series, we will discuss how pharmaceutical wholesale distributors can benefit from implementing pharmaceutical software to help comply with DSCSA regulations and automate the process of managing data.

Wholesale distribution businesses across all industries require processes and systems for managing their business. At the onset, this usually involves installing an introductory accounting solution, such as QuickBooks, to manage a company’s core financials.   As a business grows and order volume increases, there will come a time when additional software is needed.  It is at this stage that a company start evaluating a fully integrated solution to handle a business’ entire operation – from accounting to order entry and processing, to inventory management, contact management, eCommerce and more. For pharmaceutical distribution businesses, this functionality is required in addition to industry specific tools.  For this reason, pharmaceutical businesses should look to implement proper ERP software with industry specific functionality from the get-go, as opposed to starting with introductory software. Not only do regulatory bodies require companies to comply with certain standards, but having proper software in place to manage these requirements also provides a sense of security and helps ensure trust for customers and vendors throughout the supply chain.

When it comes to DSCSA requirements, ERP software with pharmaceutical specific features provides functionality for:

Transaction Reporting (T3)

Automatic tracking of information stored to one level back and one level forward
Ability to enter complete transaction tracking for each product/lot back to the manufacturer
Automatic printing of Transaction Report (T3)
Easy email and printing of Transaction Reports to the lot level for each product for a given sales order
Ability for customers to access and print Transaction Reports remotely over the internet (from an online B2B portal)

Suspect and Illegitimate Product Handling and Notification

Quarantine of products to prevent them from being allocated/shipped

Transfer to a quarantine location
Changing status of the specific lot(s) to prevent them from being allocated

Suspicious order monitoring
Automatically placing a hold on any sales order considered suspicious
Ability to store Drug Notification Form FDA 3911 at the vendor or customer level

Product Identification and Serialized Numerical Identifier (SNI)

Ability to store and print the information in the Unique Product Identifier including the product’s Serial Numerical Identifier (SNI), lot Number and associated lot expiry date

Managing Trading Partner Licenses

Storage of copy of the license(s)
Reporting of license(s) expiry dates
Association of allowable drug scheduling for each customer ship to and vendor ship from
License association to each customer/ship to
License association to each vendor ship from
Notification if license(s) are approaching expiry or have expired
Managing of a sales order or purchase order if license expired
Prevention of products being added to a sales order if applicable customer credential not achieved

As new requirements come into effect and continue to impact the daily operations of pharmaceutical wholesale distributors, it is important to ensure you have the industry specific functionality in place to comply with existing requirements and new ones as they continue to get rolled out.

Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies

Part 1: Drug Supply Chain Security Act (DSCSA) and Pharmaceutical Distribution

Part 2: Drug Supply Chain Security Act (DSCSA) Transaction Report (T3)

Part 3: DSCSA: Suspect and Illegitimate Product Handling and Notification

Part 4: Serialized Numerical Identifier (SNI) and the Drug Supply Chain Security Act

Part 5: Drug Supply Chain Security Act (DSCSA) – Annual Reporting

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Drug Supply Chain Security Act (DSCSA) – Annual Reporting

This post is Part 5 of the Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies.  Click here for Part 1, Click here for Part 2, Click here for Part 3 and Click here for Part 4. 

The DSCSA outlines specific requirements to develop and enhance drug distribution security, including establishing national standards for the licensing of prescription drug wholesale distributors and 3PLs. Part of these requirements includes annual reporting.  Essentially, as of January 1st, 2015, the DSCSA implemented a requirement around wholesale distributors reporting on licensure and other applicable information to the FDA annually. This requirement was implemented for 3PLs beginning November 27, 2014.

Based on the current information available, any establishment that engages in prescription wholesale distribution must report to the FDA and provide the appropriate contact information. The FDA requests additional information on a voluntary basis, which makes this requirement somewhat open to interpretation.  As such, this post provides highlights from the DSCSA Guidance in order to help distributors better understand who must report, what should be reported, when to report, and how to report. The FDA and CDER released a 13-minute webinar – Annual Reporting using CDER Direct – that provides additional information about the process.

Who Must Report?

Prescription Drug Wholesale Distributors – “any person who owns or operates an establishment that engages in wholesale distribution of prescription drugs”
Manufacturers that engage in wholesale distribution. However, if the manufacturer is distributing only their own drug, they do not need to report.
Wholesale distributors distributing bulk prescription drug substances.
Pharmacies that are also licensed as a wholesale distributor.

Exceptions

3PL’s only providing services related to bulk prescription drug substances do not need to report unless the substance is in finished dosage form.
Wholesale distributors and 3PL’s that distribute only over-the-counter drugs do not need to report.
Wholesale distributors and 3PL facilities only distributing and providing services related to animal drugs do not need to report.

What Should Be Reported?

Wholesale distributors should report all licenses that authorize wholesale distribution. This includes licenses the wholesale distributor holds from any state that the wholesale distributor ships human prescription drugs from, and any licenses the wholesale distributor holds from states that the wholesale distributor ships into.

The initial report submitted to the FDA by the wholesale distributor must include the following information:

Name of the company
Address of the facility
Contact information
All trading names the company does business as
Licensure information for each state, license number and expiration date for the license
Significant disciplinary actions by any state or federal agency and any documents associated with a disciplinary action(s)
Unique facility identifier – this is the D-U-N-S® number

Exceptions

Wholesale distributors are not required to report DEA registration numbers or state controlled substance licenses

When to Report

The initial reporting period was between January 1, 2015, and March 31, 2015, for wholesale distributors. Subsequent annual reporting takes place between January 1st and March 31st each year.

Exceptions

A company must submit any significant disciplinary action reports to the FDA when a final action is made.  A company must also notify the FDA if a facility goes out of business or decides to withdraw their license.

How to Report

The FDA provides a portal (FDA’s CDER Direct Electronic Submissions Portal) for submission of applicable information.  The first time a business submits a report, it requires that they create an account on the portal.

The information in this post should be used as a reference only. It is meant to provide readers an overview of the DSCSA requirement and provide easy access to FDA documentation needed to comply. The information contained in this post was extracted from the FDA Draft Guidance “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” and a newly released (Jan. 2017) supplementary guidance “Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers” that addresses many of the questions being asked.

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Serialized Numerical Identifier (SNI) and the Drug Supply Chain Security Act

This post is Part 4 of the Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies.  Click here for Part 1, Click here for Part 2 and Click here for Part 3.

One of the key requirements as part of the Drug Supply Chain Security Act is the addition of a Serialized Numerical Identifier (SNI) to be included on certain products at the individual package level. This information will provide additional identification of products in order to help keep illegitimate products from entering the supply chain. This requirement is key for product verification and the ultimate goal of a unified database which records all product information and movement along the supply chain.  The plan is to have this database be fully operable by 2023.

According to the FDA Final Guidance on “Serialized Numerical Identifier” (SNI), a product’s SNI will include the item’s National Drug Code (NDC) and unique Serial Number (SN).  SNI is also referred to as sNDC or Serialized National Drug Code.  This information will be required along with the already existing lot number and lot expiry date. These sets of information combined, make up a product’s Unique Product Identifier.
In summary, the Unique Product Identifier will consist of four pieces of information about the product; a product’s National Drug Code (NDC), and serial number (SN) – which makes up the SNI – plus the product’s lot number and lot expiry date.
The DSCSA requires that a product’s SNI be available in both human and computer readable format. It is expected that the SNI, lot number and lot expiration date will be provided on a 2D bar code. However, at this point in time, there does not seem to be a standard on the numbering or presentation of the code and readable information.

In an FDA public meeting on the “Progress Towards Implementing the Product Identification Requirements of the DCSCA” held on October 14, 2016, confirmation of the DSCSA timeline for affixing the SNI by manufacturers and re-packagers and the required use of the SNI by the entire supply chain were presented.  As such, the SNI must be placed on certain drug products by manufacturers no later than November 27, 2017.  Re-packagers have an additional year to comply with the requirement as the deadline for them is November 27, 2018.

Once the new SNI is added to the packaging of products, trading partners will be required to only buy and sell products encoded with product identifiers (unless grandfathered under section 582(a)(5)) of the DSCSA. The table below shows the timeframes required for each phase of the implementation.

As per the deadlines above, a Readiness Survey released by the HDA Research Foundation Manufacturer Serialization Readiness Survey Executive Summary concludes that 89% of manufacturers surveyed will meet the November 2017 deadline with at least some of their products. However, the survey continues to say that only 66% of manufacturers surveyed will have 100% of their branded and generic products serialized by the deadline.

One of the most significant questions posed by the survey, “when do you anticipate being able to provide serialized data to your wholesale distributor customers upon shipment?” shows that less than 50% will be ready for the November 2017 deadline. One-third indicated between November 2017 and 2023. Another 20% were unsure when the data would be available.

Although manufacturers may not meet the required deadlines, it is important for pharmaceutical wholesale distribution companies to be ready with processes and have systems in place to buy and sell product with SNI information. The implementation of software to manage these new requirements is not mandatory, however, the addition of the SNI adds another layer of complexity that will make it virtually impossible to manage without proper ERP software with pharmaceutical functionality in place.

Stay tuned for installment 5 of the Series in which we will discuss the requirements for trading partners to maintain accurate information about those they buy from and sell to.

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DSCSA: Suspect and Illegitimate Product Handling and Notification

This post is Part 3 of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies. Click here for Part 1 and click here for Part 2. 

As discussed previously, one of the main reasons for the “Drug Supply Chain Security Act (DSCSA)” is to prevent the insertion of illegitimate products into the drug supply chain. In this third installment of the Series, we will discuss what pharmaceutical distribution businesses need to know to identify, handle and notify the FDA in the event they come across a suspect/illegitimate product in the supply chain.

The DSCSA references a document, revised in December, 2016 titled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. This document explores scenarios for product entering the supply chain and then provides recommendations on how trading partners can identify and determine if product is suspect, how to notify the FDA in the event of identifying product as suspect and how to terminate a notification if a suspicious product is “cleared” and no longer suspicious.

Identification of Suspect Product

A “Suspect Product” as defined in the Federal Food, Drug, and Cosmetic Act FD&C is a product for which there is reason to believe is counterfeit, stolen, adulterated such that the product would result in serious adverse health consequences, is potentially a subject of fraudulent transaction, or appears unfit for distribution. In general, trading partners need to be more vigilant when receiving products and maintain awareness about suspicious activity or potential threats to the supply chain. The DSCSA document dictates that trading partners be more vigilant in a variety of scenarios, including:

When purchasing from a new trading partner
When receiving unsolicited sales offers from unknown sources
When purchasing from the internet from unknown sources
When purchasing from a source that a trading partner knows has been involved with suspect products
When product is in high demand and was previously in short demand
When products have suspicious packaging/labeling (ie. misspelling, different drug identification, missing lot or expiration date information)
When product has a finished dosage or imprint different from what the FDA has approved
When prices are too good to be true
When packaging appears to have been tampered with

Handling of Suspect Product and Notification

As of January 1st, 2015 the DSCSA requires trading partners, upon determining that a product in their possession or control is illegitimate, to notify the FDA and all immediate trading partners (that they have reason to believe may have received the illegitimate product) no later than 24 hours after making the determination. Once this is complete, the trading partner must “quarantine” and remove the product from the supply chain until the suspect product is cleared.

The next step involves immediately launching an investigation in coordination with applicable trading partners, validating the product using Transaction History and Transaction Information. It is the responsibility of the trading partner who launched the investigation to maintain all records pertaining to the investigation for no less than 6 years, and as part of the process, submit and record a form – FDA 3911 Drug Notification – to the FDA. Note that starting 6 years from the date of the DSCSA enactment, trading partners will also have to verify the product packaging including the standardized numerical identifier (SNI). This will be discussed in the next part of this Series.

Termination of Notification of Illegitimate

Upon determination that the concerns around a product being suspect are not valid, the FDA and all trading partners must receive notification. The trading partner who originally identified the product as being suspicious and as a result submitted an FDA 3911 form, must complete and submit a new FDA 3911 form to the FDA, indicating that they have evidence that the product in question is not suspect. This submission for termination of the original suspect notification is known as a “request for consultation with FDA” and is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Managing Requests and Submitting Information

Under the DSCSA, trading partners are required to have a system in place to (1) quickly respond to a request from the FDA for verification of a product, (2) quarantine a suspect product and (3) promptly start an investigation. There is no requirement currently that a trading partner manage any of these processes electronically, however, certain systems provide functionality for managing the processes and requirements outlined as part of the DSCSA.  For example, the right system allows trading partners to:

Store detailed information on lot controlled products, sales and purchase history (Pedigree and Transaction Reporting)
Manage information and images pertaining to the shape, size and description of product
Quarantine and remove product from the supply chain that is considered suspect

Keep your eyes open for the next post in this Series around the requirements and timing of “Product Serialization” (SNI) management.

Information in this post was taken from the DSCSA, Draft Guidance for Industry DSCSA Implementation: Identification of Suspect Product and Notification and other various presentations provided by the FDA. The information contained herein is provided as a summary and guidance only. For specific requirements go to “Drug Supply Chain Security Act (DSCSA)” and associated FDA Guidance Documents.

 

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Drug Supply Chain Security Act (DSCSA) Transaction Report (T3)

This post is Part 2 of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies. Click here for Part 1. 

The requirement to track products is not new to the pharmaceutical industry. For years there have been various requirements around tracking lot numbers (batches) of products and their expiry dates and Pedigree management (tracking of supply chain members involved with the purchase and sale of product). For the most part, it has always been the responsibility of the manufacturer, repackager and primary distributor to keep track of specific information. This, combined with information in the previous legislation, made it difficult or near impossible to track back through other trading partners that took ownership of the product throughout the supply chain in order to easily manage a recall. Furthermore, there was little ability to determine if a product was legally or illegally injected into the pharmaceutical marketplace. With the advent of the Drug Supply Chain Security Act and more specific regulations, traceability has improved.  In the second installment of this Series around the DSCSA, we will provide information on the specific traceability requirements small-medium size pharmaceutical distribution businesses must comply with in order to run their business.

As of July 1st, 2015 the “Drug Supply Chain Security Act (DSCSA)”, Section 582 requires that all “Trading Partners” including manufacturers, repackagers, wholesale distributors, and dispensers not accept pharmaceutical products unless the trading partner they receive the product from can provide specific information about the product. This specific requirement dictates that every shipment moving through the supply chain include a Transaction Report or T3. Essentially, where Pedigree tracks historical information about a specific lot and the trading partners involved, a T3 or Transaction Report includes the same information in addition to more details about the product and a statement of  legitimacy.  Pedigree details are part of the Transaction Report which passes from the existing owner to trading partners downstream. Every time product changes ownership, the new owner gets added to the Transaction Report and there is only one Transaction Report required per product/lot number. This allows each trading partner to verify that the movement of product is legitimate and legal.

The Transaction Report breaks into 3 distinct pieces:

Transaction Information

The T3 Report requires the following transaction information:

Name of the product
Strength and dosage
Specific NDC#
Number of containers
Lot number of the specific product
Date of transaction and shipment
Business name and address of the trading partner sending/receiving the product

Transaction History

The T3 Report requires the recording of the product’s entire transaction history (Pedigree) starting with the manufacturer. Details in the DSCSA and associated FDA generated documents, provide guidance on when a product’s ownership is transferred and when the corresponding T3 needs to be updated to include the transaction.

Transaction Statement

The transaction statement records the following information and requires that the trading partner transferring ownership of the specific product adhere to the following information.

Is authorized under the DSCSA
Received the product from a trading partner that is also authorized under the DSCSA
Received the transaction information and statement from the trading partner
Did not knowingly ship a suspect or illegitimate product
Has systems in place to comply with verification requirements
Did not provide false transaction information or knowingly alter the transaction history

For the most part, the industry has combined the above information into one document. When a product has a change of ownership, the trading partner must provide all applicable information for each lot of the product to the new owner of the product. The DSCSA dictates that a product shall not be received into the receiving trading partner’s inventory until a complete and accurate Transaction Report is provided by the trading partner shipping the product.

Currently, there no requirements around a business managing this information electronically, however, the time it takes to manually enter and record the data and keep accurate records makes this task very time-consuming and error-prone.  The best way to manage this information is to find a full inventory and accounting system that also has specific pharmaceutical industry functionality such as the above.  This is especially important as regulatory parties add new information to the list for tracking and recording. For example, starting in 2017 for manufacturers and 2019 for distributors, serialization per unit will need to be recorded and trading partners should expect more enhanced product tracking in 2023.

Keep your eyes open for next week’s installment of the Series where we will discuss the requirements for how trading partners handle “suspect products”.

Information in this post was taken from DSCSA Implementation: Product Tracing Requirements — Compliance Policy and other various presentations provided by the FDA. The information contained herein is provided as a summary and guidance only. For specific requirements go to “Drug Supply Chain Security Act (DSCSA)” and associated FDA Guidance Documents.

 

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