Techsol offers Computer System Validation (CSV) services for many global pharmaceutical organizations and Contract Research Organizations (CROs) as part of GxP system implementation for Electronic Data Capture(EDC), Clinical Trial Management, Drug Safety and Medical Communications.
Our domain experts have extensive experience in completing system validation activities by using the GAMP5 risk-based validation framework.
We have delivered over 100+ COTS system implementation and upgrade projects across various pharma industry verticals to help clients account for 21 CFR Part 11 and EU Annex 11 regulatory compliance.
We have delivered several Independent Verification & Validation projects utilizing industry best practices. Our CSV services include:
Independent and/or full validation services for implementations, Data Migrations, Systems Migrations, Application Integrations.
Risk assessment based validation standards built on industry best practices like GAMP v5.
Ready usable/updateable Validation kits for regulatory compliant applications, data migrations and most common system integrations (e.g. ERP, CMS).
Global delivery Model of local and offshore enabling rapid deployment and delivering greater value.