Articles tagged with “gmp-compliance”

MES & EBR in Pharma: A Guide to GMP Compliance & Efficiency

Learn how MES and Electronic Batch Records (EBR) improve pharma manufacturing. This guide explains benefits for GMP compliance, data integrity, and review-by-ex

30 min read

1/6/2026

mes electronic batch records pharma manufacturing gmp compliance 21 cfr part 11 review by exception data integrity pharma 4.0

Quality 4.0 in Pharma: A 2026 ROI & Economic Analysis

Explore a 2026 ROI analysis of Quality 4.0 in pharma manufacturing. Learn how technologies like AI & digital twins drive up to 45% cost savings and 40% capacity

25 min read

12/14/2025

quality 4.0 pharma 4.0 pharmaceutical manufacturing return on investment digital twin ai in pharma eqms cost of quality gmp compliance

NetSuite ERP Modules for Pharma Labs: GMP, FDA Compliance

Learn how NetSuite ERP modules support U.S. pharmaceutical manufacturing labs, covering GMP, FDA (21 CFR Part 11) compliance, and integrations for quality and production.

50 min read

6/10/2025

netsuite erp pharmaceutical manufacturing gmp compliance fda regulations 21 cfr part 11 quality management lab operations supply chain erp modules life sciences

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