Articles tagged with “biotech-manufacturing”

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

Learn a proven framework for CDMO selection in pharma and biotech. This guide covers a data-driven process using scorecards, due diligence, and governance KPIs.

35 min read

1/6/2026

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