Articles tagged with “biotech-manufacturing”

Pharma MES & eBR Software Guide for GMP Manufacturing

Review commercial software solutions for GMP-compliant manufacturing. Compare pharma MES, electronic batch records (eBR), and ERP systems for 21 CFR compliance.

70 min read

3/2/2026

pharma mes electronic batch records gmp software part 11 compliance manufacturing execution biotech manufacturing pharma erp qms software

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

CDMO Selection Guide: Due Diligence, Scorecards & KPIs

A proven framework for CDMO selection in pharma and biotech, with scorecards, due diligence checklists, and governance KPIs — updated April 2026 with BIOSECURE Act, Catalent/Novo deal, and EU GMP Annex 1 impacts.

35 min read

1/6/2026

cdmo selection contract manufacturing pharma outsourcing due diligence governance kpis supplier scorecard biotech manufacturing vendor evaluation