Document Control for Medical Device Companies
Article Context:
This morning I’m looking out the window of my home office, watching the palm fronds blow with a small lake in the background, at 70 degrees in Florida. What does that have anything to do with document control OR medical device companies?
Well, if I were my dad, who had open heart surgery in August, it would mean that if doc control hadn’t been in place, it’s very likely that the artificial valve put in his heart might be faulty and he wouldn’t get a chance to do Anything after his operation. He’s back to his old active self, enjoying views of the mountains and wildlife in Colorado, thanks to those who managed everything related to his artificial valve!
Part of that process is ensuring a document management system is in place, beyond just doc control. Ideally, it’s an electronic document management system since we’re well into the 21st Century now. Surprisingly, many companies are still on paper instead of the cloud.
So what’s involved to get an eDMS in place?
Many med device companies do have some kind of document management system in place to produce a required design history file per the FDA’s 13485 guidelines. These companies also need to capture various forms of data from the contract manufacturing organization or CMO, including design verification along with validation testing of their eDMS.
Additionally, design controls, equipment specifications, materials, and technician training need to be completed. All of this documentation is an integral part of product lifecycle management.
Before any medical device can be released onto the market, the burden is on device producers to demonstrate that their product does what it’s supposed to. That can be an extremely labor-intensive process since the FDA demands Lots of paperwork documenting everything from the design process to manufacturing specifications.
In particular, your CMO plays a critical role in developing and maintaining the device master record (DMR). The FDA will check the DMR against your design history record (DHR) to ensure consistency before your product goes to market.
The DMR could contain thousands of lines of information for complex products. Your manufacturer should have a computerized system, such as product lifecycle management software, to create and maintain the information needed in the DMR.
A traceability matrix is also invaluable for following the flow of med device development from beginning to end. Traceability requires showing the relationships between all of your design controls, including how design inputs relate to design outputs and how design validations relate to end-user needs.
As your customer base grows, so will the many needs of the above increase, and the need for an enterprise document management system. Welcome to Compliance Group’s eDMS/eQMS to handle all of these needs.
Back to the potato analogy, if you were to compare another food, the hamburger, to QA and QC, it would look like this, thanks to Royal Chemical’s.
And this is why it’s so good to have proper people in place for QA and QC to make your product sizzle! And for burger lovers, who wouldn’t enjoy this kind of Quality Control testing a lot more!
Would you like to know more about Quality Assurance and Quality Control process in your organization? Contact sales@complianceg.com to discuss your needs.
FAQ's
What is document control?
A document control system is a systematic process of organizing, tracking changes in a document, authorizing, distributing, storage and security. The document control process is instrumental in maintaining document integrity and traceability.
Why do we need document control?
It helps to reduce errors in documentation. In addition, the documents are secured and stored to have quick access to all the data when required, as document control systems provide a streamlined pathway for the document process. Finally, it gives the users quick access to documents providing a collaboration facility to work on the document while reducing production bottlenecks.
What do document control procedures include?
The document control procedures include
- Document indexing.
- Control over versions
- Reviewal and approval process of documents
- Document revision
- Document Archiving
- Documents available for retrieval whenever required for inspections and audits.
What is the difference between document management and document control?
Document Control
Document control is managing and controlling the documents enforcing procedures and practices for creation, review, editions, and accessibility. In addition, it refers to the security and credibility aspects of the documents.
Document Management
Document management is digitalizing the paper documents, creating them, indexing, validating, editing, and versions updating whenever required and storing them. So, this means that a controlled document is formerly a managed document in the system.
Document Management and Document Control are intricately connected, neither of which the process becomes invalid. Because without document management, there is no aspect of securing it where it means document control. Likewise, the organization lacks security and cannot comply without document control.