SVC / 02
Laboratory Software Validation
Qualification of analytical instrument software and chromatography data systems used in QC and R&D laboratories, aligned to 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.
- [✓]Instrument and software inventory with GxP impact assessment
- [✓]CDS configuration review (Empower, LabSolutions, OpenLab and similar)
- [✓]IQ / OQ / PQ execution including analytical method verification support
- [✓]Part 11 controls: audit trails, e-signatures, user access and roles
- [✓]Data integrity and ALCOA+ gap assessment
- [✓]Periodic review and requalification support
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Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.