Inventory & Accounting ERP Software Blog

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.


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.


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.


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.


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


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.


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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Drug Supply Chain Security Act (DSCSA) and Pharmaceutical Distribution

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

If you’ve had any association with the pharmaceutical industry over the past 2-3 years, it would be a safe bet to say that you are probably “aware” of the FDA requirements “Drug Supply Chain Security Act (DSCSA)”, signed into law by President Obama in November 2013.

The DSCSA was written in an attempt to provide guidance to the pharmaceutical industry relating to the traceability of pharmaceutical products in the supply chain. The idea is to provide all trading partners the ability to easily identify and determine if product(s) in the supply chain are legitimate or have been injected into the system for illegitimate reasons. The DSCSA also provides requirements to help businesses in the distribution supply chain ensure all trading partners are legitimate, with active and non-revoked licenses.

Now, more than 3 years later, although most players in the pharmaceutical industry know about the Drug Supply Chain Security Act and general requirements, the specific details and timing of various phases are still a bit foggy.

As experts1 in the industry, the FDA have put together many reports, presentations, slide shows etc. available on the topic for review by anyone interested.  However, many small pharmaceutical distribution businesses do not have the time or bandwidth to stay current with constantly changing regulations. To help summarize the DSCSA requirements and what it means to the pharmaceutical distribution industry, we will be writing a series of posts that summarize the important details and current implementation times.

Throughout the series, we will dissect the Drug Supply Chain Security Act and applicable information available, into reasonable segments and provide information needed to allow distributors to get a better understanding of the act and how it will impact their operations now and in the future.

Topics in the Series include:

Product Traceability (Transaction Report) – Requirements for tracking products and recording information as part of Transaction Reports (T3).
Suspect and Illegitimate Product Handling and Notification – What to look for now and in the future as product packaging changes.
Product Identification (Serialization) – Understanding the implementation of the Standardized Numerical Identifier (SNI) and how and when trading partners are required to comply.
Report Licensure – Requirements as to what information to submit to the FDA. Ability to track information pertaining to trading partners within the supply chain to ensure they have an active (not expired or revoked) license, for a specific location.
Managing the Data – What’s needed to manage all the information.

Stay tuned for the next post in the Series about Transaction Reports (T3) and be sure to subscribe to our blog for more information!

1 The content of the FDA presentations is intended only to provide a summary and general overview. They are not intended to be comprehensive nor do they constitute legal advice.

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Replacing Manual Processes with eCommerce Integration

Picture This: You started an eCommerce site two years ago, and ever since have had a team of employees dedicated to managing all aspects of the sales, order and shipping process. New products are manually added to the website, and employees are responsible for updating inventory quantities and prices upon receipt of new inventory into the warehouse and when pricing changes. When a customer places an order online, employees pull this information down from the eCommerce site and then manually re-key the information into your order entry/accounting software. Once an employee enters this order into the system and reviews the information to check the customer’s credit status, it gets sent to the warehouse for picking. When an order is received into the warehouse, employees pick, pack and ship the items, and then send the appropriate shipping information back to sales staff so that they can update the customer.

To your delight, over the past couple of months, online sales have taken off and business is booming. Yet, employees are having a hard time keeping up with the increase in demand and the tasks outlined above, and as a result, orders are getting lost, data entry is messy and staff morale is in decline. It’s time for you to hire some new employees to manage the increase in order volume and reduce the strain on existing staff members…or is it?

While hiring new staff will likely ease the burden placed on your current employees, adding new salaries onto your payroll may not be the best way to go about managing company growth. Will these new salaries negate the increased profits you have from your increased web sales? What if online sales continue to grow? Will you need to hire even more staff?

Hiring additional employees when order volume increases is a natural reaction, however, finding a back-end inventory and accounting ERP solution to integrate with your eCommerce site is a better alternative. In fact, an inventory and accounting system combined with appropriate business processes will not only alleviate the need for hiring new staff but also reduce the amount of administrative work existing employees deal with, giving them more time to focus on sales and customers.

Benefits to eCommerce Integration

For starters, when receiving new items into the warehouse, product only needs to be entered into your inventory and accounting ERP software, which will then push product information including descriptions, pricing, and quantities, online. This eliminates the need to re-enter the same product into your back-end ERP system and then online to your eCommerce site. As product gets sold online, order information flows directly from the website into your inventory and accounting system, updating quantities available and allocating inventory for picking. This eliminates the need to manually enter a new sales order every time a customer places an online order.

Once an order has made its way into your system, traditionally if the order has not been paid in full, or if the customer has credit with the company, someone needs to check that the customer is within their credit limit, prior to the warehouse picking the order. However, this functionality can be automatically defined in your inventory and accounting system. Users simply set up criteria for evaluating orders, such as product availability, customer credit limit, and total order amount, and if all criteria are met the order gets sent through to the warehouse for picking – without a human having to manually perform any tasks.

Although at this point in the process most companies will require human involvement to actually pick, pack and ship the order (we can’t all have Amazon picking robots after all), once those processes are completed and recorded in the software, the eCommerce store will now have access to the same updated inventory information, without someone manually updating the website.

As you can see, inventory and accounting software integrated with your eCommerce site alleviates the need for hiring new staff to manage the processes of an eCommerce business and frees up current staff from managing too many administrative tasks. In addition, ERP systems also include functionality to cover many other areas and processes within a business as well as provide opportunities for automation.

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Blue Link Food Distribution Software Makes Food Logistics’ FL100 List

We’re excited to announce that Blue Link Food Distribution Software has been included in Food Logistics’ Top 100 Software and Technology Providers list!

We’re honored to be included in the annual list (which is in its 13th year) for the fourth time as one of the top software and technology providers that play a critical role in the processes of food and beverage manufacturers, foodservice distributors, and grocery retailers.

The Rising Importance of Food Software

Do you or someone you know have a food allergy? The answer is most likely yes. With approximately 15 million Americans affected1, undeclared allergens in food supply such as peanut, tree nut, milk, egg etc., are the primary cause of food recalls. Others include several bacterial contaminations such as Salmonella and E. coli, and, what’s even more surprising is that every year, food recalls cause the US economy $7 billion2. What’s the financial damage to impacted businesses?  Quite a lot of bacon actually- around $10 million per company3! The costs associated with this figure include notifying trading partners and consumers in the supply chain, retrieving and destroying affected goods etc.

If you’re a food distributor or food manufacturer, these numbers are certainly alarming. If a recall happens to your business, you need to have exceptional processes in place to help you deal with the aftermath quickly and efficiently.  Food distribution software with product traceability increases the speed and accuracy of which you react to a food recall.

There are vast capabilities within the software such as tracking product along the distribution chain with lot numbers. You can also trace the history of a specific product prior to you purchasing it and have detailed records of where the product was shipped to from your location. You can quickly generate reports based on data on associated supplier, lot number, expiry date, and production date as well as customer information so you can notify all impacted parties and begin the recall process as quickly as possible.

Keep in mind, your ability to respond quickly and efficiently to product recalls can not only save your business money but can be the difference between maintaining your customers’ trust and loyalty in your brand and losing them to your competitors.

What makes Blue Link a top food distribution software vendor?

Blue Link’s extensive lot tracking/traceability features are key components in achieving and sustaining FDA/ISO/CFIA compliance for our food distribution customers. Additional features include:

Landed cost tracking – allows food distribution customers to account for all costs associated with getting product to their warehouse and customers such as duty, brokerage, freight, insurance, storage etc.
Multiple units of measure: unit conversions – buy and sell the same products by weight, multiple containers, volume etc.
Price matrices with automatic product mark-up, volume discounts and contract pricing (individual or group).


Full Press Release
Blue Link Named to Food Logistics’ 2016 FL100+ Top Software and Technology Providers List
Vaughan, Ontario—December 16, 2016 — Food Logistics, the only publication exclusively dedicated to covering the movement of product through the global food supply chain, has named Blue Link to its 2016 FL100+ Top Software and Technology Providers list.

The FL100+ Top Software and Technology Providers list serves as a resource guide of software and technology providers whose products and services are critical for companies in the global food and beverage supply chain.

“The software and technology sector continues to generate new and exciting opportunities for growers, food manufacturers, grocery retailers and the many logistics providers that support them,” notes Lara L. Sowinski, editorial director at Food Logistics. “Today’s cloud-based solutions and mobile connectivity are helping create tools that are more flexible, affordable and responsive, making software and technology even more valuable to those in the global food supply chain.”

Companies on this year’s 2016 FL100+ Top Software and Technology Providers list will be profiled in the November/December 2016 issue of Food Logistics, as well as online at

About Food Logistics

Food Logistics is published by AC Business Media, a business-to-business media company that provides targeted content and comprehensive, integrated advertising and promotion opportunities for some of the world’s most recognized B2B brands. Its diverse portfolio serves the construction, logistics, supply


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Multi-Currency Accounting and Inventory Software

Think about the purchases you’ve made in the last few months. Have any of them been cross-border? If the answer is yes, you’re not alone. With the emergence of the omnichannel shopping experience, consumers are experiencing seamless buying across borders and are increasingly purchasing from foreign websites and businesses for product that they either can’t find in their home country or are too expensive to buy locally. What does this mean for your own business? If your business operates globally or is preparing for cross-border expansion, it is critical to have an accounting and inventory software that will support multiple currencies so you can remain competitive in today’s buyer landscape.

Whether you’re a small retail business or an established importer and exporter, the challenges of buying and selling in different currencies are common – the fluctuating cost of inventory, tracking ever-changing exchange rates, and reporting currency profits and losses are just a few factors to consider.  And these challenges are even greater if you use spreadsheets to monitor this information since you’re more likely to make errors, resulting in inaccurate financial data – it’s enough to pull your hair out!

With the proper multi-currency accounting and inventory software, you can track and manage real-time exchange rates in order to have a clear perspective of the financial landscape – as it stands at present time. Other advantages include:

Creating Customer Invoices and Vendor Purchase Orders in Multiple Currencies

Setting default currencies for customers and vendors who operate in a different currency ensures that any transaction which you perform with them will be converted to your home currency without any additional manual calculations or entries. And, to sweeten the deal – customer quotes and purchase orders can be created in the customer or suppliers’ currency, and once converted to a sale or purchase, the system will record the transaction in the appropriate currencies (i.e. payable in the supplier’s currency with a foreign exchange difference and the inventory or expense in the home currency). This eliminates the manual process of having to remember to convert pricing for inventory or factor in exchange rates when posting the transaction.

Global Accounting Consolidation

If you handle accounting for your business, you know how complex reporting can be when dealing with multiple currencies. Imagine having the ability to convert transactions from the currency in which they took place to your home currency – how much time and effort do you think you’ll be able to save by having the converted amount automatically recorded into the G/L? This is just the tip of the iceberg – by eliminating the manual processes of factoring in various currencies, closing times are accelerated and transparency is maximized. And, you can monitor unrealized foreign exchange gains or losses by running appropriate reports at any point in time.

Bank Transfers

Other important functionality is the ability to perform bank transfers between accounts with different currencies.  Entering the amount in one currency which you transferred and the amount in the foreign currency which it was converted to will allow the system to determine the amount to record in the exchange difference account without the need for an additional entry.

Landed Cost Tracking

With accounting and inventory software that also includes robust landed cost features, there is the additional benefit of knowing the true cost of inventory with exchange rates included. The software will perform foreign exchange calculations on any landed costs associated with a purchase – costs such as freight, customs, brokerage etc.

Of course, global businesses need more than just multi-currency functionality in their accounting and inventory software to operate seamlessly. Other factors to consider when evaluating vendors for your global business include multiple languages which is especially beneficial to businesses with clients and vendors requiring information and documents in another language – an example of this would be sending invoices in your customer’s language. It is also important to keep in mind your unique industry-specific needs such as global compliance adherence, regulations and taxation.

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