June 25, 2019
Deviations: Beyond the Basics: There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference between theory and practice when it comes to handling deviations and keeping oversight. Save yourself valuable time by implementing ideas presented in this blog on deviations and avoiding common pitfalls. Taking the regular deviation workflow as basis, we provide recommendations derived from many years of experience with both smooth-running systems and companies struggling with their deviation workload.
We will use the scheme below to guide us through the deviation workflow and highlight the points where you can make the difference in your company.
Clearly, the proper handling of deviations and CAPAs requires one or more systems to be in place. The Quality Assurance department is owner of this system and responsible for assigning owners to deviations and keeping track of deadlines. This should be a daily or weekly routine to prevent build-up of a backlog.
Take care to design your system and train your personnel to prevent these common pitfalls:
This blog is densely packed with recommendations beyond the basics of deviations and should help you refine your company processes. If you do not wish to reinvent the wheel or you would just like to learn more about effectively managing deviations, reach out to us and profit from our many years of experience.
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