As most of you know, document control is critical in medical device development and manufacturing. This was also the case when I worked as an engineer in a medical device company.
- Engineering records drive medical product development, and the company quality system and Standard Operating Procedures (SOPs) govern how business is conducted.
- Organized, revision-controlled, and auditable records are fundamental to maintaining regulatory compliance.
- Capturing changes to the Design History File (DHF ) and the Device Master Record (DMR) is necessary in order to demonstrate the entire design history of your device to the regulatory bodies.
Document control, however, was often associated with manual, tedious work, and a high risk of errors in my former company. The reason? We had to do everything manually.
This is what we did
We created and updated company data in design programs, SOPs, memos, and spreadsheets. Changes were printed out and routed for signatures in colored folders. Product information was communicated to internal teams, outsourced manufacturers, and suppliers via email, phone, or disconnected chat tools.
Critical product records, including the DHF, the DMR, and the Bill of Material (BOM) were kept in a combination of engineering vaults, spreadsheets, and paper files. Final BOMs were usually loaded into enterprise resource planning (ERP) systems.
Then this happened
You see, the problem with this approach is that you cannot accurately update large, complex, and continually evolving product records like the DHF, DMR, and BOMs. It is both inefficient and associated with high degrees of risk.
At the same time, these records are highly relational and include various associated data and files, like revisions, parts, and drawings. And they must all be properly linked and tracked.
Spreadsheets, servers, and paper files alone do not provide integrated ways to aggregate all related item data.
Thirdly, maintaining a system of spreadsheets in a validated state is both time-consuming and challenging. Trust me on this one! Spreadsheets do not live up to the level of organization and accountability required in the medical device industry.
Spreadsheets are not cut out for this
Speaking of spreadsheets, they do not have integral processes for managing engineering change orders (ECOs) and cannot be used to control device master record changes, manage associated files or create proper documentation for the DHF. The FDA requires that ECOs are properly verified, validated, reviewed, and documented in the DHF of the product. Manual routing of paper ECOs in colored folders is just inefficient and creates bottlenecks.
The overall problem with this approach was that all design efforts are iterative processes with many changes and reworks along the way. Capturing the many changes that occur simply became a maintenance nightmare for the spreadsheet owner. That was me!
So, one day I was on the phone with a friend who was working in a similar position. Jokingly, I was complaining about my spreadsheet “situation.” Then he said: You need automated document control, Mr. Skogen!
He explained the ins and outs of that foreign concept to me. Then it dawned on me. And I realized, this would make my working life so much easier!
What we should have done
We should have had access to a system that allowed us to create as many regulatory structures as we wanted to manage and have them managed in the same way so that they are automatically created, tracked, and baselined. Other document structures such as the Technical File could also benefit from being managed in the same way as the DHF and the DMR.
Quite frankly, such capability should be a standard requirement in the medical device industry, if you ask me.
That is why we developed Aras Medical Device
In Aras Medical Device, we have developed features to handle these document structures in the same way, with the same requirements for change management and traceability, and achieve:
- Accurate project update status
- Faster documentation retrieval and more assured regulatory compliance by capturing product data as it happens, not as an afterthought—risk avoidance
- Efficient regulatory submission workflow that is futureproofed. Face an audit with confidence knowing that information is held or federated into a single knowledgebase, readily available
- Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands.
Please check out our Aras Medical Device overview page to learn more.