ERP Validation in a GxP Environment
Compliant with GAMP 5 Second Edition
21 CFR Part 11
GMP Annex 11
Deploying or upgrading an ERP (Microsoft Dynamics / Navision, Divalto, Infor, Cegid, Oracle) in a GxP context? ADN handles the computerized system validation (CSV) of your ERP whatever the solution, with an approach focused on the processes actually subject to regulation: batch management, traceability, quality control and audit trail.
Our approach to ERP validation
We scale the validation effort to the system's real risk and its GMP regulatory context (FDA/Europe). Specifications target the critical GxP processes, which avoids validating functions with no quality impact.
Our validation deliverables
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Regulatory impact analysis and GAMP 5 categorization
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Specifications targeting critical GxP processes
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Validation Plan
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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, access control, electronic signatures
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Requirements-tests-results traceability matrix
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Validation report
ERP systems covered
Our consultants have validated ERP systems in the pharmaceutical, cosmetics, medical device and biotech sectors: Microsoft Dynamics / Navision, Divalto, Infor Cloud Suite, Cegid and Oracle, among others.
Frequently asked questions
Which ERP processes must be validated in GxP?
We prioritize processes with a quality or patient impact: batch management and release, traceability, access control, audit trail and bills of materials. Purely financial functions are generally out of the GxP scope.
Can a cloud ERP such as Infor Cloud Suite be validated?
Yes. Validating a cloud ERP then includes a review of the service agreements of both the vendor and its integrator, which is the opportunity to communicate the regulatory requirements and the shared responsibility model between vendor, integrator and end users.
Does validation differ between FDA and CE marking?
The methodological foundation remains GAMP 5 Second Edition, but the documentation and traceability requirements adjust to the target framework: 21 CFR Part 11 and Part 820 on the FDA side, ISO 13485 for CE marking.
What is CSA and does it change ERP 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 ERP 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.