LIMS Validation in a GxP Laboratory
Compliant with GAMP 5 Second Edition
21 CFR Part 11
GMP Annex 11
The LIMS is the most sensitive system in the GxP laboratory: sample management, out-of-specification (OOS) results, data integrity and audit trail. ADN supports the computerized system validation (CSV) of your LIMS, from pre-scoping through to maintaining the validated state.
Our approach to LIMS validation
We start with a scoping study and a regulatory impact analysis, then apply a GAMP 5 categorization to calibrate the strategy. Specifications target the sensitive functions: sample management, result processing, OOS workflow, audit trail and electronic signatures. The risk analysis drives the mitigation measures, of which testing is part.
Our validation deliverables
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Scoping study and regulatory impact analysis
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GAMP 5 categorization and validation strategy
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Specifications: samples, results, OOS, audit trail, electronic signatures
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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 and GMP Annex 11 compliance testing
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Traceability matrix and validation report
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Product expertise and maintenance of the validated state on a time-and-materials basis
LIMS we master
Our consultants have hands-on experience with the market's major LIMS: LabWare and SampleManager LIMS, including large-scale multi-site projects.
Data integrity and compliance
Validation ensures compliance with the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available), the foundation of the data integrity required by 21 CFR Part 11 and GMP Annex 11.
Frequently asked questions
What is ALCOA+ data integrity for a LIMS?
ALCOA+ is the set of principles ensuring that laboratory data is attributable, legible, contemporaneous, original and accurate, and that it remains complete, consistent, enduring and available throughout the lifecycle.
How are OOS results handled during LIMS validation?
The out-of-specification results workflow is a critical point of the specifications: validation tests verify the triggering, traceability and locking of decisions, in connection with the audit trail.
Should a cloud or SaaS LIMS be validated the same way?
A hosted LIMS requires including supplier and infrastructure qualification in the strategy, but the risk-based GAMP 5 logic remains the same.
What is CSA and does it change LIMS 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 LIMS 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.