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An internal deviation occurred because the user's signature was truncated in the completed document in Samsung Biologics.
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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.
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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.
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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.)
