Developing and using technical documentation and standard processes is a way of life for FDA-regulated companies. The Code of Federal Regulations (Title 21, CFR Part 820) states repeatedly that the medical device manufacturers must “establish and maintain” procedures. To do so, regulated manufacturers should define, document, and implement process documentation. After implementation, it is critical to then follow up, review, and revise these technical pieces as needed.
Setting up a formal system to monitor your company’s process documentation annually or bi-annually helps you make sure they stay current. When your company is audited or inspected by the FDA, you will need to show a system for monitoring and controlling your technical documentation and standard operating procedures. In short, our recommended approach is to:
- Evaluate documentation on a periodic basis
- Update or retire the processes as the need for it changes
- Schedule dates for your process documentation reviews in advance
- Lack of written process documentation
- Outdated or unsuitable documentation
- Failure to adhere to available process documentation
Not passing an FDA audit can be costly, making timely reviews and documentation management even more important. Below we have outline our top five tips for successfully managing documentation and standard processes in order to stay compliant and consistent in quality.
5 Best Practices for Managing Technical Documentation & Standard Operating Procedures
If you are an FDA-regulated company, your company should already have an established process in place of how internal documentation is managed. Be sure you establish a process for making your employees aware of new documentation and any associated training required. If you don't already have these in place, start it today!
Here are the top 5 best practices we recommend for managing technical documentation and standard operating procedures in regulated environments:
- Set up a system to monitor process documentation to make sure it stays current. Request that employees report needed changes, updates, or concerns to their supervisor or Quality Manager.
- Assign approved versions of technical documentation a version number. Give major revisions a new number (1.0, 2.0); give minor changes a new increment number (1.1, 1.2).
- Ensure your standard processes are created in version-controlled documents. Set up a practice and communicate to your employees that approved versions of standard processes can only be found via the company’s intranet or internet in a read-only format. Do not consider printed versions of technical documentation as current.
- Insert a watermark on all draft copies of your documentation. This will clearly identify that these documents are not yet approved.
- Be aware that as your business processes change, so will your standard operating procedures. Make sure to schedule the annual or bi-annual reviews of your technical documentation in advance. As mentioned above, it is important that you can show a system for monitoring and controlling your technical documentation in the event of an FDA audit or inspection.
Creating well-written documentation eliminates the need for interpretation by employees and makes sure that processes and procedures are followed as intended.