Wonderware, Ignition, DeltaV, Experion — validated for GMP.
Historian, alarms, batch, HMI — validated with data-integrity and cyber-hygiene bundled in.
SCADA and DCS validation covers the control systems running manufacturing and utilities — alarm handling, interlocks, trending, historian data and the integrity of what reaches the batch record. The software component is categorised under GAMP 5; the equipment it controls is qualified against EU GMP Annex 15, with critical process parameters carried into the challenge tests.
Outcomes you can expect
- SCADA scope + risk
- Alarm & historian validation
- Cyber-hygiene baseline
SCADA / DCS Validation is delivered by our validation & compliance services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Computer System Validation (CSV), Computer Software Assurance (CSA), AI Validation Services (Annex 22), FDA 21 CFR Part 11 Compliance.
SCADA and DCS in GMP: The Historian and Alarm Record Challenge
SCADA and Distributed Control Systems are GxP-critical when they directly control GMP manufacturing processes — fermentation, filling, sterilisation, environmental monitoring — and generate electronic records of those processes. The two SCADA functions that generate the most validation and data integrity scrutiny are the process historian and the alarm management system. The historian records all process parameter values with timestamps; the alarm management system records all process parameter excursions, their detection, and their acknowledgement. Both are primary GMP records for batch release and regulatory inspection.
The most common historian data integrity failure in SCADA validation is timestamp accuracy: historian timestamps that are derived from individual workstation clocks rather than a synchronised NTP time server create irreconcilable discrepancies between the historian record and other GMP system records (MES, LIMS) that independently record the same process period. This discrepancy is not a technical nuisance — it is a data integrity finding that calls the reliability of the entire historian record into question. Our SCADA validation includes specific time synchronisation verification as a standard protocol element.
Cyber-Hygiene as a GxP Validation Element
SCADA and DCS cybersecurity is no longer separate from GxP validation — it is a GxP validation requirement. Both FDA and EMA have published guidance that links cybersecurity to data integrity: a GxP system that can be accessed by unauthorised users, or whose historian records can be modified by an undetected intrusion, does not meet the data integrity requirements of EU GMP Annex 11 and 21 CFR Part 11. Cyber-hygiene baseline documentation — network segmentation, patch management status, antivirus or application whitelisting, remote access controls, and physical access controls to the OT network — is therefore part of the SCADA validation package.
Our SCADA validation bundles a cyber-hygiene baseline assessment with the standard IQ/OQ/PQ execution. The assessment documents the current network segmentation between the corporate IT network and the OT network, the patch management status for all SCADA components, the remote access protocol and its authentication controls, and the physical access controls to control room and field device locations. Where gaps exist against NIST CSF or IEC 62443 baselines, we produce a prioritised remediation plan that QA and IT can address collaboratively.
Sources
Primary documents referred to on this page, from their official publishers.
- 21 CFR Part 11: Electronic Records; Electronic Signatures · eCFR (US)
- Data Integrity and Compliance With Drug CGMP: Questions and Answers · US FDA
- EudraLex Volume 4: EU Good Manufacturing Practice guidelines · European Commission
- EU GMP Annex 11: Computerised Systems (current version) · European Commission
- EU GMP Annex 15: Qualification and Validation · European Commission
- ISPE GAMP 5 Guide, Second Edition · ISPE
See it on your own system.
Bring a URS or a system. We show you the validation package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan and scope