Good Documentation Practices have been a hot topic in the medical device industry for a long time. It appears simple and straight forward but for some reason it remains a critical topic in the industry. I have seen it in Good Laboratory Practices (GLP’s), current Good Manufacturing Practices (cGMP’s), Good Clinical Practices (GCP’s) and the Quality System Regulation (QSR). It is a common theme….documentation that is illegible, not attributable, incomplete, inaccurate or backdated. The FDA has written 483’s, warning letters, and has taken official action against organizations as a result of poor documentation. Poor documentation has cost organizations millions of dollars and the real key to GDP is simply the ability to enable ”Document Reconstruction”. Document reconstruction is the single most important aspect of GDP. If your documents could stand on their own and tell a true and accurate story of what took place 10 or 20 year from now you are on the right track. I think they should call it Good Business Practices, because it is so critical to the success of any organization. The key principles that I like to remember about GDP are “ALCOA”…Attributable, Legible, Contemporaneous, Original and Accurate. These simple concepts can make a world of difference if you are trying to reconstruct any documentation that would allow you to make critical decisions. A former FDA investigator/reviewer once said to me ”Can you imagine what it would be like to have the responsibility to make a decision that could impact millions of people and all you have in front of you is documentation that someone created 5 to 10 years ago? How confident would you be if you could not clearly reconstruct the documentation?” Remember, your documents could play an important role in someone’s life.
By Scott Cook — Director of Quality and Compliance — Cogmedix