MAKE YOUR SYSTEM COMPLIANT WITH REGULATORY REQUIREMENTS
COMPUTERIZED SYSTEM VALIDATION IS TRADITIONALLY DEFINED AS A SYSTEMATIC PROCESS BASED ON DOCUMENTED EVIDENCE, AIMED AT DEMONSTRATING THAT SOFTWARE OPERATES ACCORDING TO SPECIFIED REQUIREMENTS AND REGULATORY EXPECTATIONS.
The mission of our CSV department is to support companies in bringing their systems into compliance and keeping them aligned with the highest standards of quality and current regulatory agencies’ needs.
Protect your processes, validate your systems.
Key Activities for Computer System Validation
- Definition of initial User Requirements (UR) and drafting of detailed specifications (URS - User Requirements Specification and FRS - Functional Requirements Specification) to support both pre-purchase and post-purchase phases
- Validation Plan
- Risk Assessment
- Risk Management
- Evaluation of supplier development activities: FS (Functional Specification), SDS (Software Design Specification), HDS (Hardware Design Specification)
- Issuing, review, and execution of qualification protocols (IQ - Installation Qualification, OQ - Operational Qualification, PQ - Performance Qualification) and acceptance tests (FAT - Factory Acceptance Test, SAT - Site Acceptance Test)
- Traceability Matrix
- Validation Report
- Development and implementation of Standard Operating Procedures (SOPs) to maintain the validated state of systems for both IT and OT areas and ensure business continuity (examples include: access management, configuration checks, periodic reviews, Backup & Restore, Disaster & Recovery, Audit Trail Review)
- Periodic Review execution to maintain or restore system compliance status
- Data Integrity Assessment, and Remediation process
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