Electronic Signatures Articles

Articles tagged with “electronic-signatures”

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, and controls for data integrity and audit-ready systems.

60 min read

7/25/2025

21 cfr part 11 fda compliance gxp electronic records electronic signatures artificial intelligence data integrity regulatory affairs quality assurance system validation

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.

40 min read

6/9/2025

lms life sciences compliance fda 21 cfr part 11 gxp training audit trails electronic signatures validation

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

netsuite sap erp life sciences regulatory compliance fda 21 cfr part 11 gxp audit trails electronic signatures enterprise resource planning pharmaceutical industry

Understanding 21 CFR Part 11: Electronic Records & Signatures

Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. This article covers its history, purpose, and significance in the pharmaceutical industry.

40 min read

6/4/2025

21 cfr part 11 electronic records electronic signatures fda regulations pharmaceuticals gmp compliance regulatory history data trustworthiness