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Documentation of Quality System Processes: Speeding FDA Audits in Medical Device Manufacturing

Working in one of the most regulated industries, medical device manufacturers are subject to stricter requirements and audits by the US Food and Drug Administration (FDA). Quality system implementation and management makes compliance more easily achievable for manufacturers. However, failure to implement can result in product quality and regulatory compliance issues as well as a lack of process improvements.


In many cases, medical device manufacturers fall short on giving the appropriate attention to making sure their quality system documentation is written to FDA standards. Many companies fail to realize that properly documenting quality system processes actually speeds FDA audits. Documentation is also a key factor for many FDA in their overall determination of the organization's compliance profile.

Will your organization be prepared when the FDA shows up at your door? Is your process documentation up to date? Do your employees know how to interact with the FDA inspectors while they are on site?  Below are a few valuable pointers for successfully surviving an FDA audit.

7 Tips to Make Your Documentation FDA Audit-Ready

Overlooking the importance of documentation in an FDA audit is a weakness for many medical device manufacturers. Use our tips below to make sure you have efficient documentation in place.

    1. Evaluate documentation completeness.Text image
  1. Create and maintain a master folder with the necessary documentation and associated review and approval sign-offs.
  2. Keep all documentation up to date with current procedures.

  3. Refer to the CPGs to identify the scope and regulations associated with the pending inspection.
  4. Be prepared to have the necessary resources to accommodate the number of FDA inspectors assigned and to manage the inspection itself.
  5. Identify the relevant documentation to be supplied for the inspection.
  6. Review past inspections and current procedures.
Don't have the in-house resources to complete your technical documentation project? Medical device manufacturers that utilize professional technical writers to develop their quality system documentation tend to perform significantly better during the FDA regulatory inspections, achieve reduced time to market from regulatory submissions, and increase staff effectiveness in developing required compliance documentation.

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Topics: outsourcing, controlling cost, Process documentation