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We use the 21 CFR Part 11 module for pharmaceutical industry, specifically in this example to record the creation / amendment / extension and ultimately retirement of Standard Operating Procedures (SOP’s) within the business. Recently as part of an SOP amendment the document was sent out to 3 x parties for signature. The first one received and signed OK, but the second one commented that they had never received the envelope. When we went looking in the audit history it appeared as if the envelope had been moved into a folder called “Bin” for some reason. This is not a folder we’ve created or are familiar with, so we can only assume that someone manually moved it here.
The idea / request is simple - the current audit trail for envelopes, particularly when using the 21 CFR Part 11 module for regulated pharmaceutical industry - is not detailed enough. We went into the audit thinking we could identify who moved the envelope here and when, but no this level of detail is not provided.
The audit trail for an envelope should provide this level of detail - it would allow us to problem solve why a multi-party signing “stalled” and importantly with who so we can provide them with training. At present there is nowhere near enough detail to show precisely what happened to an envelope as it moves through the system - every single action should be record along with who performed it and when and this audit should be immutable.
Many thanks
Chris Totten
Senior IT Architect, Norbrook Laboratories Limited, UK