Pharma OT & GxP Cybersecurity Handbook 2026: Protecting Pharmaceutical Manufacturing, Process Control and Batch Systems: Data Integrity, Annex 11, 21 CFR Part 11, CSV/CSA and IEC 62443

By Prof Kai London

A batch record with a broken audit trail isn't a paperwork problem - it's a recall, a warning letter, or worse. In pharma manufacturing, cybersecurity and data integrity are the same conversation.

This handbook protects pharmaceutical manufacturing, process control and batch systems where GxP and OT security meet - covering data integrity, Annex 11, 21 CFR Part 11, CSV/CSA and IEC 62443 in one working reference.

Built for pharma OT engineers, quality and validation teams, and manufacturing IT leads who need systems that satisfy both the regulator and the attacker's absence:

Data integrity principles applied to process control and batch systemsAnnex 11 and 21 CFR Part 11 requirements translated into OT-specific controlsCSV/CSA validation approaches that hold up alongside cybersecurity evidenceIEC 62443 zones, conduits and security levels for GMP manufacturing environments

Work through the task-based reading routes and role-relevant examples, then build a manufacturing security programme that survives both an inspection and an incident.

This is an independent educational publication, not official training, certification, legal advice, or a guarantee of compliance.

• Format: Paperback
• Language: English
• ISBN: B0HKG9P3F4
• ISBN13: 9798175778695
• Release Date: September 2026
• Publisher: Independently published
• Length: 610 Pages
• Weight: 2.28 lbs.
• Dimensions: 9.3" x 1.4" x 7.5"