To ensure that Life Sciences companies record and store the information required by most regulatory bodies, an ERP system must have certain specific functionality. When evaluating ERP systems, it is important to delve deeply into the capabilities in specific areas to ensure that the supplied features are robust enough to support industry requirements.
During this blog series, we are going to cover 10 Requirements Life Sciences need addressed by their industry specific ERP systems. This article discusses the first two: traceability and as built / as maintained configuration records.
Serial and Lot Number Traceability
When it comes to saving lives, minutes matter. That’s why fast, efficient and accurate track and trace capabilities are crucial for Life Sciences companies. They are required to be able to demonstrate that they can identify the location of every component with a potential quality issue, whether it’s in stock, in finished goods or in use at a customer site. While it’s important to be able to do this quickly and accurately to pass an audit, it’s even more important to do it in the event of a recall.
Many ERP vendors say they can do track and trace, but their capabilities stop at the factory walls. Some don’t have the ability to connect to specific supplier lots—crucial when there’s a suspicion of a bad component.
Some stop tracking at the point of shipment. They don’t retain information about shipped or maintained units—leaving a gigantic black hole in essential information. Both cases may needlessly increase the scope of a potential recall because the manufacturer can’t identify affected units easily.
Another key aspect of tracking and tracing is the ability to assign both a serial number and a lot number to components. This additional degree of refinement may enable the manufacturing to limit the scope of recalls even further, helping to reduce costs and protect the brand’s reputation without endangering patients.
As Built and As Maintained Configuration Records
As mentioned above, some systems draw the line at tracking and tracing once a product leaves the shipping dock, but that leaves out a large portion of the product life cycle. Medical devices undergo periodic maintenance and updates. While a specific unit may not have had an affected component at the time of shipment, it’s possible that one was installed during maintenance. The manufacturer needs to be able to identify that and include those “in use” products in recalls and audits to be certain they are included.
In addition, if the change must be field applied, this ability will be necessary to identify units that need updating and units that have already been updated. Detailed insight into “as maintained” records ensures that the company doesn’t recall units or send techs out on needless service calls for devices that are already compliant.
To learn more about ERP in Life Sciences companies, download our free “ERP in Life Sciences” white paper.
The post Specific Life Sciences Requirements for ERP – Part 1 appeared first on Merit Solutions.
