Articles tagged with “electronic-batch-records”

Electronic Batch Records in Biotech: GxP & Software Guide

Explore GxP requirements for Electronic Batch Records (EBR) in biotech. Covers FDA 21 CFR Part 11 compliance, validation, and current software options.

35 min read

2/7/2026

electronic batch records biotech manufacturing gxp compliance 21 cfr part 11 mes software data integrity annex 11 computer system validation

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