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    1121 Ideas

    Jihyun BaeNew Voice

    Request for improvement of signature functionParked

    An internal deviation occurred because the user's signature was truncated in the completed document in Samsung Biologics. *image removed* The CFR part11 also states that signatures should be in human-readable form in printed matter. In addition, as an GMP company, SBL's signature cut is against internal regulations.Below is SBL QA's opinion.-----------------------------------------Since the signature 'Person/Date/Time' information cannot be verified/tracked in the finalized document itself, it is considered GDP violation (Originality, Readability, Accuracy, etc.). Since the E-FORM is the original and does not exist as a separate True Copy to compare/prove the existing signature, it is considered appropriate to capture the loss of records in the original as a Deviation. For the truncated information, it seems that you can check it through Audit Trail, so impact seems to be small, but it seems appropriate to capture the event and impact verification results through Deviation.----------------------------------------If the Impact is small but captured as a deviation within the SBL, the system needs to be improved to prevent the issue from recurring. Guiding users through the process is not a complete prevention of issues. Therefore, I would like to ask if one of the three below is possible through system improvement.- Make the 'Sign field' the same as the signature size so that the user can recognize the signature size.- If the signature is truncated from the document, an error occurs and finish is not possible.- Resize the completed signature before finish (We understand that can re-sign after the signature has been canceled.)

    christottenNew Voice

    More detailed historical audit / history for envelopes as they are sent and signedIdea Submitted

    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 TottenSenior IT Architect, Norbrook Laboratories Limited, UK