SCADA and Supervision Systems Validation
Compliant with GAMP 5 Second Edition
21 CFR Part 11
GMP Annex 11
SCADA and supervision systems are among the most complex to validate in a GxP environment: real-time data acquisition, alarm management, traceability of critical process parameters and data integrity. ADN supports the computerized system validation (CSV) of your SCADA systems, from categorization through to operational qualification.
Our approach to SCADA validation
These systems typically fall into GAMP 5 categories 4 or 5 (configured or custom software), which requires a substantial validation effort. We carry out a criticality analysis of alarms and instrumented parameters to focus testing on the functions that protect product quality.
Our validation deliverables
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Regulatory impact analysis and GAMP 5 categorization
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Specifications targeting critical parameters: temperature, pressure, humidity, alarms
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Criticality analysis of alarms and instrumented parameters
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Functional risk analysis
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IQ/OQ/PQ protocols and scripts
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21 CFR Part 11 compliance testing: audit trail, time-stamping, access control
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Traceability matrix and validation report
SCADA platforms we master
Our consultants work on the market's leading platforms: Wonderware (AVEVA), Ignition (Inductive Automation), Siemens WinCC and Schneider Electric, in pharmaceutical, biotech and regulated industrial contexts.
Frequently asked questions
Why is alarm criticality analysis key in SCADA validation?
Not all alarms have the same impact. Prioritizing their criticality makes it possible to target validation tests on those that genuinely affect product quality or safety, and to define the associated actions.
Which GAMP 5 category does a SCADA fall into?
A SCADA is most often in category 4 (configured) or 5 (custom development), which implies detailed specifications and in-depth OQ/PQ testing.
How do you ensure the real-time data integrity of a SCADA?
By verifying time-stamping, the audit trail, access control and the reliability of acquisition, in line with the requirements of 21 CFR Part 11.
What is CSA and does it change SCADA validation?
Computer Software Assurance is the FDA's 2022 approach that refocuses testing effort on patient risk and product quality while reducing low-value documentation. It applies fully to SCADA projects.
Is it possible to relieve my users of tasks seen as time-consuming?
Yes, we offer solutions that let AI agents run tests in place of your key users, and help overcome writer's block when drafting specifications.