Who can validate my LIMS or lab software (CSV / CSA)?

Computerized system validation shows software is fit for intended use. GAMP 5 promotes a risk-based approach; FDA's Computer Software Assurance guidance focuses effort on critical functions. 21 CFR Part 11 applies when FDA-regulated electronic records and signatures are used.

What the method covers

LIMS, ELN, CDS, SDMS and standalone instrument software, including upgrades and configuration changes.

Applicability caveats

• Validation scope depends on intended use and configuration, not the product name.
• Vendor documentation helps but does not replace your validation.
• Data integrity controls must be verified, not assumed.

Request this test · LIMS implementation & validation consulting