MES Validation for GxP Manufacturing
Compliant with GAMP 5 Second Edition
21 CFR Part 11
GMP Annex 11
The MES is at the heart of GxP manufacturing: management of manufacturing orders, electronic recipe management, real-time traceability and production data integrity. ADN supports the computerized system validation (CSV) of your MES across the entire lifecycle, from the initial strategy to maintaining the validated state.
Our approach to MES validation
The MES industrializes the electronic batch record and review by exception. We target testing on these sensitive functions and on the interfaces with the ERP and equipment, integrating automated testing approaches where needed to speed up campaigns.
Critical GxP MES processes
-
Manufacturing orders and guided execution
-
Electronic recipes and process parameters
-
Electronic batch record and review by exception
-
Deviation management during production
-
Audit trail and electronic signatures
Our validation deliverables
-
Regulatory impact analysis and GAMP 5 categorization
-
Specifications targeting critical manufacturing processes
-
Functional risk analysis
-
IQ/OQ/PQ protocols and scripts
-
21 CFR Part 11 and GMP Annex 11 compliance testing
-
Traceability matrix and validation report
MES we master
Our consultants have hands-on experience with the major MES: Werum PAS-X, Siemens Opcenter, Apriso (Dassault Systèmes) and Rockwell FactoryTalk, in demanding pharmaceutical and biotech environments.
Frequently asked questions
What is an electronic batch record (EBR) and why validate it?
The electronic batch record replaces the paper record by guiding and recording production in real time. Its validation ensures data integrity and the reliability of review by exception.
Can MES validation tests be automated?
Yes. Automated testing tools can speed up repetitive OQ/PQ campaigns, provided the test tool itself is qualified according to a risk-based approach.
How do you validate the interfaces between MES, ERP and equipment?
Interfaces are tested as critical points: the integrity and consistency of exchanged data, error handling and recovery are part of the validation scope.
What is CSA and does it change MES 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 MES 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.