Articles tagged with “electronic-records”

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

21 cfr part 11 data integrity fda regulations electronic records electronic signatures computer system validation annex 11 audit trails

The Role of WORM Compliance in Biotech Data Integrity

Learn how WORM (Write Once, Read Many) storage ensures data immutability and integrity for electronic records in the highly regulated biotechnology industry.

55 min read

8/10/2025

worm compliance biotechnology data integrity data storage regulatory compliance immutable data data governance electronic records

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

Understanding Pharma Regulatory Compliance Software Solutions

Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.

20 min read

6/20/2025

audit-trails data-integrity electronic-records eu-annex-11 fda-21-cfr-part-11 gmp pharmaceuticals qms-software quality-management regulatory-compliance

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