Achieve Your Goals

Computerized System Validation (CSV) & QA Oversight

We deliver GxP-compliant computerized system validation (CSV) strategies that meet 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.

Our expertise includes

Validation planning & risk-based assessments.
Reviewing validation deliverables: URS, FRS, IQ/OQ/PQ, traceability matrices.
Audit & gap assessments of clinical systems and vendors.
Training and awareness for end users on validated state & data integrity.

Systems supported

eTMF, CTMS, EDC, eCOA, IRT, Safety Databases, PV Systems.