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A Guide to 21 CFR Part 11 and Annex 11 Compliant Signatures

With e-signature validation guide

Mohammad Ramezanalizadeh / Unsplash

Lexi Sharkov
Bio

ZenQMS

Wed, 11/05/2025 - 12:01
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We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily necessity.

ADVERTISEMENT

But how you collect those electronic signatures matters, especially for GxP-regulated organizations.

The typical workaround of printing, signing, scanning, and emailing creates compliance risks and breaks the digital chain of custody. A dedicated e-signature tool is the smarter move, but not all platforms are created equal. Many standard business tools simply don’t meet the strict GxP compliance standards, leaving you exposed during an audit.

So, how do you get it right? Here’s what you need to know to make sure your e-signature process isn’t just efficient but provably compliant.

 …

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