Validation that holds up in front of a regulator.
Computerized System Validation (CSV) is the documented process of proving that the computer systems, software, and automated processes used in a regulated environment do what they are supposed to do — reliably, securely, and reproducibly. It is how you demonstrate to an inspector that the data your decisions rest on can be trusted.
Valitech delivers CSV for pharmaceutical and life sciences organizations in full alignment with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5. Our work has supported EU, PIC/S, and ANVISA inspections, and has been cleared in USFDA audits.
Why validation is not optional
- Regulatory compliance. FDA, EU GMP, and equivalent regimes require that computerized systems used in critical processes be validated and stay validated.
- Data integrity. Validation demonstrates that records are accurate, attributable, and traceable — and that data cannot be silently lost, corrupted, or altered.
- Risk mitigation. Defects are found and closed before they reach production, not after a batch is affected.
- Operational consistency. Systems behave predictably across conditions, so the business can rely on them day to day.
- Inspection evidence. The validation record is the proof an auditor asks for. Without it, the system is treated as unqualified regardless of how well it works.
Where CSV is required
Any system that affects the quality, safety, or compliance of a product or process falls in scope. In practice, that includes:
- Manufacturing systems
- Laboratory systems and analytical software
- Clinical Trial Management Systems (CTMS)
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP/SAP) systems
- Computerized control systems for equipment (PLC, SCADA, DCS)
- Quality Management Systems (QMS)
- Electronic Batch Record (EBR) systems
- Environmental and building monitoring systems
- Document and record management systems
- Data backup and recovery systems
- Cloud-hosted and SaaS systems
Our approach
Regulatory standards. Every engagement is built on FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 — the frameworks that govern electronic records, electronic signatures, audit trails, and system validation.
Risk-based effort. Validation is scaled to the risk a system actually poses to product quality, patient safety, and compliance. High-risk systems get depth; low-risk systems do not get padded with documentation nobody needs. This is what GAMP 5 asks for, and it is where validation budgets are usually won or lost.
V-Model documentation. Deliverables follow the V-Model approach set out in GAMP 5 – A Risk Based Approach to Compliant GxP Computerized Systems, so every requirement is traceable to the test that proves it.
What you receive
- GxP Assessment
- GAP Assessment
- User Requirement Specification (URS)
- Functional Risk Assessment
- Installation Qualification (IQ) protocol and report
- Operational Qualification (OQ) protocol and report
- Performance Qualification (PQ) protocol and report
- Traceability Matrix
- Validation Summary Report
Every document is audit-ready on handover — written to be read by an inspector, not filed and forgotten.
The business case for validation
Validation is a compliance requirement, but it also pays for itself. Done well, CSV reduces cost and risk across the business:
- Reduced risk of non-compliance fines
- Avoided product-recall costs
- Faster regulatory approvals
- Improved operational efficiency
- Minimized system downtime
- Lower long-term cost of maintaining compliance
- Reduced quality-control costs
- Greater trust and reputation with regulators and partners
In short: by validating systems properly, pharmaceutical companies save money through fewer fines, recalls, and downtime, and save time through smoother inspections and faster approvals — which over the long run means stronger profitability and a more defensible market position.
Validated systems, and the IT beneath them
A validated application running on unqualified infrastructure is still an audit finding. Because Valitech also delivers infrastructure qualification, IT SOPs, and backup and restoration, the team that validates your systems is the team that qualifies what they run on — one vendor, one accountable record.