11.18.2014 Nancy Watts

If it’s not documented, it didn’t happen

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“If it’s not documented, it didn’t happen.” – Every Regulatory Agency Inspector

The last thing Quality Management wants to see on an inspection report is “Your firm failed to establish and follow written procedures…” but so many firms, large and small, are finding that establishing and following written procedures are both daunting tasks. Perhaps establishing and updating procedures is a focal point for your company, especially with a robust CAPA and Change Management program, but vigilance on following and enforcing those procedures can be draining on management as well as your quality assurance team. Here is something to remember: You are NOT alone! Even the most diligent Quality System in the pharmaceutical, biotechnology, medical device and clinical research organizations have been cited for failure to follow procedures. This is a large maze to traverse and keep intact at the same time. Some helpful tips to ensure success in your documentation practices:

Stay current with FDA guidance documents

These documents are available on the FDA website in draft form prior to approval, it may help to appoint a QA representative to check regularly. If you want some ideas on how to best implement good documentation practice, you can view this presentation from the World Health Organisation that gives a great introduction to the subject. Also, the folks at Compliance Insight have put together a video to help even newcomers to the subject get started on the right foot. The video is called '22 tips on writing for FDA compliance' and you can watch it below. https://www.youtube.com/watch?v=wiPDWPh65CE

Quality Assurance must always have final approval for procedures.

QA is your last line of defence prior to the customer/market, they are also your internal FDA experts along with Regulatory Affairs.

Internal Audit, Audit, Audit…

Internal audits should be structured, rigorous and procedurally driven. Most importantly, they should always be documented.

Nearly every procedure should have a documentation step

I honestly can't think of one procedure that doesn’t require documentation, even if it is only to say that training has occurred.

Thorough training is a must

Training is a cornerstone of effective good documentation practice. Depending on the change, it should be completed pre-implementation, post-change approval, and potentially annually.

Use the right tools

If you are struggling to manage this manually (and more people do), we recommend looking at one of the range of software solutions available. There are a wide range solutions available, from traditional enterprise QMS software to modern web based quality management platforms. Final words - for anyone who is having issues organizing, tracking documentation and training, make sure to ask for help and stay ahead of the inspection! If you have any questions, let us know in the comments below.

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Published by Nancy Watts November 18, 2014
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