Articles tagged with “electronic-signatures”

DocuSign in Pharma: A Guide to 21 CFR Part 11 Compliance

An analysis of how DocuSign is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its modules.

45 min read

10/23/2025

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21 CFR Part 11: IT Guide to Electronic Records & Signatures

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

45 min read

10/12/2025

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21 CFR Part 11: Electronic Records, Signatures, AI, GxP Compliance

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance (including finalized CSA and AI credibility framework), and controls for data integrity and audit-ready systems. Updated February 2026.

65 min read

7/25/2025

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LMS for Life Sciences: Compliance Requirements and Evaluation

Evaluate LMS platforms for life sciences. Understand key compliance requirements: FDA 21 CFR Part 11, GxP, electronic records, and audit trails for validated training.

45 min read

6/9/2025

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NetSuite and SAP ERP: Regulatory Compliance in Life Sciences

Compares NetSuite and SAP ERP systems' technical capabilities and regulatory compliance features for pharmaceutical and life sciences companies.

20 min read

6/8/2025

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Understanding 21 CFR Part 11: Electronic Records & Signatures

Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. Updated for 2026 with the latest FDA guidance on electronic systems, Computer Software Assurance (CSA), and GAMP 5 Second Edition.

40 min read

6/4/2025

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