ERP & FDA Validation: Tracking DMR and DHR

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The development of a medical device can take years and cost tens of thousands of dollars in research and development. During this time, documented information around the development is accumulated. 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 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 ERP system helps overcome common challenges in DMR and DHR management.

Information Consistency

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 Medical Devices Surgerykept current and organized in order to be compliant. However, the risks involved are both regulatory and operational.

Working with hard copies or even spreadsheets opens the door to error, whether it is someone referring to an obsolete version of the file or having multiple working copies of the same file. These methods could have serious consequences in other industries, but the stakes are even higher for FDA regulated manufacturers. The results could range from improper inventory numbers to faulty manufacturing and product recall.

As an example, IMMY, a manufacturer of diagnostic tests and reagents, was leveraging a paper-based validation system that did not allow for growth while complying with FDA regulations. They were running several systems of record and disparate solutions that led to data being handled multiple times, which caused an increase in errors and risk with FDA compliance. With the move into a new facility in 2016, the company needed an ERP solution that could scale with its growing business requirements.

Utilizing an ERP system for electronic documentation allows IMMY to update one central repository, ensuring all its employees are accessing the same version of the file. This supports its FDA compliance mandate and ensures all team members are in lockstep while fulfilling their individual job functions.

“With our previous system, we lacked the functionality necessary to automate our FDA validation requirements, which resulted in a time-consuming and costly manual process. With Copley, we now have one system that handles all of our business requirements, including our need for data integrity as well as our documentation for GMP risk areas, leading to an improvement in our overall business processes.”

Sean Bauman, CEO at IMMY


Role-based Access to Files

Having accurate product information remains essential throughout the life of an FDA regulated product; 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 should not be allowed.

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 supplier to access part-specific information while limiting their 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 being out of compliance.

Tracking Change History 

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.  Managing these changes with physical files or spreadsheets is as complex as it is dangerous. If documentation specialists need to hunt down an undocumented change or an overlooked error, review deadlines could be missed, audit questions could go unanswered, and product delivery schedules could be put in jeopardy.

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

 ERP & FDA Compliance


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