Practical guides on GAMP 5, 21 CFR Part 11, PLC and SCADA engineering, OT networks, instrumentation and project delivery. Written by engineers who've done it — not by people who've only read the regulation.
The V-model, risk assessment, validation lifecycle, document structure and GAMP 5 categories. Start here.
Audit trails, electronic records, e-signatures and access control for FDA-regulated SCADA systems.
How to write, structure, document and validate PLC programs for GMP environments. Platform-agnostic.
SCADA and HMI design, configuration and validation — historians, audit trails, user management and more.
OT network design, segmentation, cybersecurity and IQ documentation for pharma automation.
Calibration management, field instrumentation IQ documentation and sensor validation for GMP.
How to run a pharma automation validation project as a system integrator — planning, pricing and delivery.
Cloud SCADA, AI in GMP, digital twins, ALCOA+ data integrity and the future of computer system validation.
29 production-ready GAMP 5 documents — IQ, OQ, PQ, FAT, traceability matrix, risk assessment and more. Built by engineers who understand both what the system does and what the documentation needs to demonstrate.
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