Medical & Pharmaceutical Traceability Software – What to Look For

Mark Canes

This post outlines functionality one should expect from Medical and Pharmaceutical Traceability Software.

Apart from the standard inventory and accounting ERP software, medical and pharmaceutical distributors need robust traceability to help them comply with regulatory guidelines and legislation. There are many important aspects to traceability but the core component is lot tracking to aid in FDA / ISO / CFIA compliance. In this post we will explore some of the most important software functionality for those in the medical and pharmaceutical industry.

Key Features

●   Lot tracking   ●   Landed cost tracking   ●   Serialization    ●

●   Revision Control   ●   Special Orders / Drop Shipping   ●

Lot Tracking

It is obvious that one of the most important features in ERP software for the medical and pharmaceutical industry is traceability. Despite the importance of lot traceability for the industry, many businesses are still performing these processes manually – often on spreadsheets. This is a huge cause for concern, of course; not only because it can be an arduous process but also because very costly errors can be made.

Watch out for the varying degrees of lot tracking offered by different ERP software vendors. As they are not all created equal, be sure to make an apples-to-apples comparison. The optimal lot tracking solution should include:

-          Internal and external lot number tracking

-          The ability to pre-assign lot numbers based on expiry dates

-          Proactive management of, and alerts for, expiry dates

-          Auto-generate lot numbers (optionally)

-          Printing of lot (or batch) information on packing slips, invoices etc.

Landed Cost Tracking

Medical and Pharmaceutical businesses that import product need a landed cost tracking system to accurately cost inventory and provide meaningful gross margin data. This is particularly true of generic drugs or medical devices manufactured outside the country. Factors such as duty, brokerage and freight can have a profound impact on inventory costs. In order to ensure you are making the right purchasing and pricing decisions, make sure your software system handles landed costs appropriately.

  • Define expected landed costs on purchase orders, and factor these into inventory costs – for accurate product costing
  • Ability to specify default landed cost factors by product
  • Ability to apply each landed cost factor to each line on a purchase order using one of several pro-rated methods – including a manual override for unusual situations
  • Ability to reassign landed cost components to different vendors after receipt of purchase orders – if you expected the freight cost to be Carrier A, but the invoice arrives from Carrier B, you need to be able to account for it appropriately
  • On-screen lookups and drill down to landed cost details – making it easy to see how the landed cost reconciles back to the supplier cost

Medical distributors who supply medical equipment, and big-ticket devices, need to track each device individually. Of course, for such companies serialization is important throughout the entire process, purchasing, sales and even RMAs.

Revision Control

Internal lot numbers (or other methods) may be used as a means of keeping track of product revisions. For example, you may have a product that has received blanket FDA approval under one product code (SKU), but you carry several different versions (minor revisions). Splitting these into separate SKUs is a non-starter, but you still need a method of differentiating the revisions. This is ideally tracked at the lot / batch level.

Special Orders / Drop Shipping

Medical products can be complicated and made-to-order, resulting in special orders. Ensure your software can accommodate these special orders and manage straight-forward drop shipping.

To fulfill the requirements of the medical and pharmaceutical industry, any software package under examination should have all of the above features. If it doesn’t, keep looking.