E-Signatures Validation
Aqsa Zaman
Pharmacist | Clinical Quality Assurance Professional | QA and Training Consultant
There appears to be some confusion regarding the validation of electronic signatures, particularly with platforms like Adobe Sign and DocuSign. Some have mistakenly assumed that these tools automatically ensure compliance without the need for additional validation efforts. However, it's crucial to understand that validation remains a necessary step to comply with regulatory standards, particularly CFR Part 11 requirements.
Under CFR Part 11, electronic signatures are considered legally binding and equivalent to handwritten signatures when certain conditions are met. However, the responsibility lies with the organization to ensure that these signatures are implemented and maintained in a manner that meets regulatory requirements. This includes validating the electronic signature process to ensure its reliability, integrity, and security.
While platforms like Adobe Sign and DocuSign offer robust features for electronic signatures, they do not inherently guarantee compliance with CFR Part 11. Instead, organizations must conduct their own validation processes to ensure that these tools are implemented in a manner that meets regulatory expectations.
In conclusion, while platforms like Adobe Sign and DocuSign offer convenient solutions for electronic signatures, they do not exempt organizations from the requirement to validate these processes. Compliance with CFR Part 11 necessitates thorough validation efforts to ensure the reliability and integrity of electronic signatures.
Let's work together to clarify misconceptions and ensure that our electronic signature processes meet the highest standards of regulatory compliance.
Clinical Quality Assurance Expert
11 个月May I piggy back on this wonderful discussion, but for DocuSign. I just learnt that they now include client email identification testing as part of the validation. That is, if the client use the DocuSign out of the box, over the cloud, with no configuration, their validation package should cover all validation requirements. There is no customization, the only user-specific part that needs to be tested would have been the user identification, which they claim they are including that in their routine validation for their clients. I have yet to review their package, but can anyone comment on the sufficiency of this approach?
Adobe sign provides validation packages for 21CFR part 11, Eudralex annex with key considerations. Validation package consists of plan, usecases, work instructions, requirement traceability and validation summary report.
Marketing Leader @ Epista Life Sciences | Life Sciences & Technology | OG TMF'er + Founder of TMF Week
12 个月Absolutely agree Aqsa Zaman, we wrote the book on this, some of which is detailed here: https://blog.montrium.com/blog/roadmap-to-validating-adobe-acrobat-sign-for-21-cfr-part-11
I was under the understanding that Adobe does provide a pre-validated version of their software for GMPs - if the software comes pre-validated and is not altered - what further validation would be required?
CEO & Consultant @ Verdandi AG
12 个月For those in the EU/EEA, do not forget to check for compliance with eIDAS, the European Regulation for electronic signatures. Checking 21 CFR Part 11 may be a first step to compliance, but possibly more aspects need to be considered. Here is the link to further information: https://ec.europa.eu/digital-building-blocks/sites/display/DIGITAL/eSignature