Validation & Computer System Validation (CSV)
Building Compliance, Quality & Data Integrity into Digital Manufacturing
What We Deliver
We provide comprehensive Computer System Validation (CSV) and qualification services to ensure that your automated systems, software, and IT infrastructure meet stringent regulatory requirements (such as 21 CFR Part 11, EU Annex 11, and GAMP 5). Our risk-based validation approach ensures compliance while optimizing project timelines and minimizing operational disruption.
Our validation engineers work closely with quality and project teams to deliver complete validation lifecycles for DCS, PLC, SCADA, MES, and customized software systems.
GxP and regulatory compliance support
Ensuring systems meet pharmaceutical and industrial
regulations.
IQ, OQ, and PQ validation services
Performing complete installation, operational, and
performance qualification.
Validation documentation and traceability
Preparing detailed records, protocols, and traceability
matrices.
Audit-ready compliance solutions
Delivering properly documented systems for regulatory
inspections.
What’s included
We deliver end-to-end Computer System Validation (CSV) services to ensure your automated systems are fully compliant, audit-ready, and optimized for performance.
- Validation Strategy & Master Planning (VMP): Risk assessments and validation plans.
- Lifecycle Documentation: URS, FRS, DS, Traceability Matrices.
- Protocol Development & Execution: IQ, OQ, and PQ testing.
- 21 CFR Part 11 Compliance: Electronic records and signatures assessments.
