ERP Software and FDA Compliance: Managing Your DMR, DHF, and Product Documentation

A properly implemented enterprise resource planning system can help keep product timelines in place and manufacturers in compliance.

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The development of a medical device can take years. Over the course of this time, product information amasses and evolves. From quality documentation and design data to computer-aided design (CAD) files and part specs, the device master record (DMR) and design history file (DHF) are critical but volatile entities in the medical device life cycle. The proper maintenance of these files is essential to not only FDA compliance but also operational success. Here are three ways an enterprise resource planning (ERP) system helps overcome common challenges in DMR and DHR management.

Version Control

Over a product’s life cycle, DMR and DHF files will be created, stored, and modified. Because these files will be submitted for FDA review, they must be kept current and organized in order to be in compliance. However, the risks involved are both regulatory and operational.

Working with hard copies or even spreadsheets opens the door to error, be it by referring to an obsolete version of the file or having multiple working copies being altered at once. These methods could have serious consequences in other industries, but the stakes are even higher for medical device manufacturers. The results could range from improper inventory numbers to faulty manufacturing and product recall. Utilizing an ERP system for electronic documentation management allows users to update one central repository, ensuring all users are accessing the same—and latest—version of the file. This supports FDA compliance and ensures all team members are in lockstep while fulfilling their individual functions.

Accessibility

Having accurate product information remains essential throughout the life of a medical device; however, DMRs and DHFs also contain sensitive, usually proprietary, information. Accessibility is an important concern, both in terms of who can access the files and who can’t.

Rather than distributing files via email or fax, the use of an ERP system allows key players to securely access a single source of truth as the product moves through the supply chain. It also empowers the system administrator to grant access in a selective manner. If, for instance, you work with suppliers that are authorized to view files for one part but not another, you no longer need to download the file to isolate that subset of data prior to distribution. Instead, you can grant permission for that user to access part-specific information while limiting access to the rest of the DHF. This ensures that employees and partners are able tap to into the information needed to do their jobs without introducing unnecessary security risks or stepping out of compliance.

Traceability

Whether correcting glitches, replacing suppliers, redesigning parts, changes to your DMR and DHF can happen at any time. Effectively tracking these changes is critical to obtaining FDA approval. Revision processes must be validated and verified, and subsequent revisions must follow these methods, with changes being documented, traceable, and approved. Quality teams handle a tremendous number of files in preparing for FDA submissions and audits, and managing all of these changes with physical files or spreadsheets is as complex as it sounds. If documentation specialists have to hunt down an undocumented change or an overlooked error, review deadlines could be missed, audit questions could go unanswered, and, ultimately, product timelines could be put in jeopardy.

With an ERP system tuned for FDA regulated environments, gathering the data needed for a change order, review, or audit is no longer such a laborious, error-prone exercise. Changes are tracked by date, time, and user, so it is clear when a change is made. This gives operations, manufacturers, and finance the details they need to operate successfully. Documentation specialists know exactly to whom they should direct questions, and with all parties in the loop, the odds of an error going unnoticed are significantly decreased.

Robert Lane

Robert Lane is CEO of the Copley Consulting Group, where he is responsible for growth strategies and the quality of all solutions and professional services provided to Copley’s clients. He is a former senior consultant with KPMG, where he helped lead the Management Consulting Practice in New England.

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