What is the requirement for GxP document retention? Can we choose a single medium (physical or electronic) for records long term preservation to avoid duplication of archived records with the exception of vital records?
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What is the requirement for GxP document retention? Can we choose a single medium (physical or electronic) for records long term preservation to avoid duplication of archived records with the exception of vital records?
Hi Lavanya,
You can choose the media which you use to produce and store your documentation. Duplication is not required.
You don’t have to print digital data and store it digitally.
If you use a complex digital system, you need to validate it and ensure it functions according to the ALCOA+ requirements.
You can find more information about the requirements in the EudraLex, Volume 4, Chapter 4: Documentation.
Thank you Yan!