.png)
The medical device industry presents many unique challenges, and not all ERP systems can handle them. In some cases, the system needs to be ‘validated,’ which is time-consuming and expensive. As the software is upgraded, it needs to be revalidated. Therefore there needs to be a solid strategy in place for handling these requirements and the best solution is a medical device ERP software such as EpiMed for Epicor.
Medical Device ERP Industry Compliance
Usually the ERP industry focuses on FDA Part 11 and ISO 13485 for medical device ERP software as the key compliance standards. These requirements are primarily around documenting processes and ensuring that the organization followed the correct procedures and documented who, when, and how those processes were executed.
Common in these kinds of compliance areas are traceability of lot numbers, serial numbers (such as for prosthetics), and, multiple lots, and serial numbering for various components of a sophisticated testing machine. In addition, specific key processes may need to be signed off by certain personnel qualified to approve that function. Test values may need to be captured, and further analysis of these values may yield whether the item passes. Biometric scanning of fingerprints, handprints, etc. may need to be used to properly identify the correct personnel performing any number of procedures.
Once all of these special procedures are set up in the ERP system, it needs to be tested to ensure the system is reliable and works according to the quality system requirements of the organization. This step is called validation, and the procedure(s) for validation (sometimes called ‘scripts’) can be automated. Suppose an ERP system is going to be updated periodically by the publisher. In that case, the same validation scripts need to be run for each revision of the software to ensure that these critical elements of functionality are in place.
What to Look For When Choosing Medical Device ERP Software
Selecting a medical device ERP software is quite a bit more complex than a standard selection. The team should have a complete understanding of the quality requirements of their organization and how these requirements can be satisfied by a system. In many cases, manual paper-based processes are being replaced, and the ERP version may appear to be more complicated or challenging to complete. However, the ability to audit results, track down certain lots of a given product is much easier with an electronic system.
When we visit medical device manufacturers, their records storage rooms are typically adjacent to their labs. When we take a look inside, there are rows and rows of 4 drawer filing cabinets, stuffed with test results, lot numbers and serial numbers. If there is a failure in the field, the effort to find every test result with a certain lot number on it is a monumental task. It’s quite concerning that there are even facilities like this still functioning on manual systems.
However, if an organization defines their needs, and provides detailed examples of their more complex requirements, they can ask the ERP vendors to demonstrate how their product handles these particular items. This is likely the best way to ensure that the medical device ERP software is a good fit.
Lastly, be careful of vendors who say their software is ‘FDA Compliant’ or ‘already validated’. Your organization’s interpretation of the standard is what defines your requirements, based on what you are manufacturing. This is why you need to review the specific functionality and ability of the ERP to be flexible enough to handle these requirements.
Contact EpiCenter Today & Speak With Our Experts for Medical Device ERP Software
The medical device industry is certainly one of the more challenging we deal with. However, our years of experience with all kinds of health sciences firms has given us great perspective. In addition, Epicor ERP (Kinetic) is an excellent medical device ERP software for building in the requirements for the medical device industry. For more information, please click the link below or contact us, and we can send you our EpiMed brochure, which explains in detail how we setup Epicor to function for your industry.