Articles tagged with “pharma-manufacturing”

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

FDA CSA Guidance: A Pharma & Biotech Compliance Guide

Understand the FDA's final Computer Software Assurance (CSA) guidance, a risk-based shift from CSV for pharma & biotech. Learn key principles for compliance.

30 min read

12/27/2025

computer software assurance fda guidance software validation gxp compliance risk-based validation pharma manufacturing 21 cfr part 11

Pharmaceutical Plant Development: From Concept to Commissioning

Learn to build a pharmaceutical manufacturing plant from concept through commissioning. This guide covers planning, regulatory compliance, design, equipment, quality, validation, and approval.

120 min read

5/22/2025

pharmaceutical plant facility development pharma manufacturing regulatory compliance quality systems validation feasibility study project execution site selection equipment