You may know the saying: “if you didn’t document it, it didn’t happen”. As cliché as that sounds, it is true. All successful businesses require a clear framework of defined policies and standardized processes. This is particularly true in the medical field. Good medical device document control allows evidence of your compliance.
Medical device document control is the foundation for your business’ QMS. You wouldn’t build a house on quicksand, so why build a business on disordered, sub-standard processes?
Sometimes referred to as document management, medical device document control streamlines your organization’s activities. Being able to track and provide evidence of your actions makes meeting customer and regulatory requirements quick and painless.
Medical device document control is a system for tracking changes, revisions, and approvals to essential paperwork throughout the medical device life cycle. It takes you from development to commercialization and beyond, while checking for adherence to company policy.
Some examples of medical device paperwork you need to control are:Documents are the Quality Manual, SOPs and Work Instructions, which are dynamic documents, whereas records are static once completed. Best practice is to always have a second person review a record and approve it prior to filing or archiving.
Whether manual or eQMS, QA Consulting can help. We can assist in your selection and implementation of an appropriate eQMS or set up a manual system and establish a purpose-built medical device document control system for you.
Document management is essential for all parts of your business. From improvements to your QMS, to review and regulatory processes, all decisions must be written down. The success of your business (and by proxy, your innovations) relies on meeting key regulatory standards. Like a well-oiled machine, effective medical device document control improves company efficiency, allowing you to breeze through audits and inspections.
Medical device document control has multiple implicit and explicit benefits, some more obvious than others. Good documentation practice (GDP) is the gold standard in the medical device development world, which helps medical device designers, innovators, and manufacturers keep accurate documents and records. These documents provide evidence of your strict adherence to company procedure, diarise the series of events, and give decision makers quick-access to version control and accountability proofings.
Knowing the “five w’s and the h” (who, what, when, where, and how) of your business increases efficiency, improves device safety, and informs future processes. Proper documentation makes things easier to follow, but is often insufficient. Good medical device document and record control is also a necessary requirement for all major regulatory bodies. For medical device companies, failing to prepare the proper medical device document and record control really is preparing to fail.
Navigating the landscape of regulatory adherence may seem bewildering. But knowing how best to write, review and store your documentation doesn’t have to be complex or tedious. Our expert team provides key regulatory insights quickly and concisely.
