Computer System Validation Services
Regulated systems demand more than functionality; they demand proof. As specialist computer system validation service providers, we offer end-to-end CSV services that look at accuracy, data integrity, and consistent performance across every GxP-impacting platform you run. Our certified computer system validation consultants ensure you’re fully aligned with 21 CFR Part 11 compliance, GAMP 5 alignment, and EU Annex 11 readiness, providing inspection-ready documentation that covers everything from requirements to PQ sign-off. We follow a risk-based Computer Software Assurance (CSA) approach, which means we allocate our testing efforts where they matter most — on critical functions that impact patient safety, product quality, and data integrity — all while ensuring compliance with regulations.
21 CFR Part 11
GAMP 5 Compliant
Risk-Based Approach
Validation Flow
Real-time process
Requirements
Risk Assessment
Testing
Documentation
04
IQ
OQ
PQ
Proven expertise that delivers compliant reults.
Every engagement is backed by a track record that quality teams and auditors already trust.
100+
GAMP 5
21 CFR Part 11
24/7
Quality you can count on. Every engagement is executed with accuracy, integrity, and a commitment to help you stay audit-ready, always.
What is Computer System Validation in Pharma?
CSV is the documented process of proving that the computerized system operates as expected, effectively and reliably, in accordance with 21 CFR Part 11, EU Annex 11 and GAMP 5 guidelines. Computer system validation should be applied to any system that generates, processes and stores the information utilized for decision-making concerning the quality of products, patient safety, and compliance.
CSV in Pharma is required whenever a computerized system:
- Generates or stores electronic records or signatures tied to product quality
- Controls or monitors a regulated manufacturing, lab, or quality process
- Feeds data into batch release, stability, or compliance decisions
- Is configured, customised, or upgraded within a GxP environment
Trusted Computer System Validation Service Providers
Our computer system validation services follow a structured 7-stage process to ensure compliance, quality, and audit readiness.
01
Requirements
02
Risk Assessment
03
Testing
04
Documentation
05
IQ
06
OQ
07
PQ
Why Computer System Validation matters
An unvalidated system isn’t a paperwork gap; it’s a regulatory and operational risk that surfaces at the worst possible moment: during an inspection.
- Regulatory compliance: Computer System Validation Services hand regulators documented proof that GxP-critical systems work exactly the way they’re supposed to. Unvalidated systems are still one of the top reasons behind FDA 483 observations and warning letters.
- Data integrity: Skip validation, and small configuration or data errors can silently throw off batch records, lab results, and release decisions.
- Audit readiness: Computer System Validation in Pharma is about having traceable evidence from URS all the way to PQ, ready to show an inspector on day one, not scrambled together under pressure.
- Product quality: Effective Software Validation Services can spot problems even before the software reaches the shop floor.
- Reliability: Systems validated are predictable, therefore have fewer breakdowns and need fewer corrections.
- Patient safety: In the long run, all electronic records about product quality serve the people who will use the product.
Specialized. Scalable. regulator- ready.
From enterprise software validation services to SCADA validation and PLC validation, our team delivers inspection-ready results across every layer of your computerised infrastructure.
Computer System Validation (CSV)
- End-to-end CSV computer system validation for all GxP-impacting systems. Our consultant team applies a risk-based methodology with complete traceability. Every deliverable is structured to withstand FDA, MHRA, and EU GMP inspection.
PLC and SCADA Validation
- Functional, integration, and performance validation of automation systems controlling critical manufacturing processes. Our SCADA and PLC validation services cover control logic verification, alarm management, network security, and 21 CFR Part 11 compliance for electronic records.
Software Validation Services for Enterprise Systems
- Comprehensive software validation for LIMS, MES, ERP, DCS, QMS, EBR, and other regulated platforms. We apply GAMP 5 validation principles appropriate to each software category, delivering audit trails and re-validation protocols to minimise operational risk.
Six steps. Zero shortcuts.
Our computer system validation consultant team follows a structured, phase-wise approach that produces complete audit trails and inspection-ready documentation at every stage of the CSV lifecycle.
GxP Assessment
Key Deliverables
- User Requirements Specification (URS)
- Functional Specification (FS)
- Regulatory Requirements Mapping (21 CFR Part 11 / EU Annex 11)
Risk Assessment
Key Deliverables
- Risk Assessment Report aligned to GAMP 5
- Risk Mitigation Strategies
- Critical Control Point Analysis
Validation Planning
Key Deliverables
- Validation Master Plan (VMP)
- Design/Configuration Specification
- Test Case Documentation
- Acceptance Criteria Definition
Testing & Documentation
Key Deliverables
- IQ / OQ / PQ Test Execution Records
- Requirements Traceability Matrix (RTM)
- Performance Test Results
- User Acceptance Test (UAT) Reports
- Validation Summary Report (VSR)
User Training & Support
Key Deliverables
- Training Materials & SOPs
- User Manuals
- Support and Escalation Procedures
Ongoing Maintenance
Key Deliverables
- Change Control Procedures
- Periodic Review Reports
- Re-validation Protocols
- Business Continuity Plan
From SCADA to ERP, We Validate it All.
As experienced computer system validation service providers, we cover the full spectrum of computerized systems across pharma, biotech, and life sciences operations.
Application Software (GAMP & EU Annex 11)
PLC and SCADA Systems
EMS / BMS Qualification Systems
Manufacturing Execution Systems (MES)
Laboratory Information Systems (LIMS)
Enterprise Resource Planning (ERP)
Electronic Batch Records (EBR)
Document Management Systems
Distributed Control Systems (DCS)
Quality Management Systems
Environmental Monitoring Systems
All Computerized GxP Systems
Regulatory frameworks we follow
Our validation approach is built directly on the standards your auditors will be checking against.
21 CFR Part 11 (US FDA)
EU GMP Annex 11
GAMP 5 (ISPE)
MHRA Data Integrity Guidance
PIC/S Guidelines
WHO Guidance
ALCOA++ Principles
Why pharma and biotech teams choose QIS
100+ Validation Projects Delivered | 16 Years of Combined Team Experience | 500+ Equipment & System Setups Qualified
Deep Pharma Domain Expertise
Our team comes from within pharma and biotech, not generic IT, so we understand GxP context, not just test scripts.
Risk-Based Validation Methodology
We size effort to actual risk, focusing on rigour where patient safety and data integrity matter most.
GAMP 5 & CSA Approach
GAMP 5 categorisation meets the FDA's CSA philosophy, critical thinking over excessive documentation.
Experienced CSV & CQV Specialists
A proven inspection track record across validation and qualification projects, anticipating what auditors will probe.
Lifecycle Coverage
From URS through IQ/OQ/PQ, periodic review, and revalidation — the entire lifecycle of the system covered.
Inspection-Ready Documentation
Each deliverable can pass the FDA, MHRA, and EU GMP review. The traceability of requirements-to-test evidence included.
Global Regulatory Alignment
Frameworks mapped to 21 CFR Part 11, EU Annex 11, PIC/S, and WHO guidance, one approach across markets.
CSV Deliverables
At the end of each CSV project, we deliver an inspection-ready set of documentation, not just test sheets.
System-Level Impact Assessment
User Requirements Specification (URS) & Functional Specification (FS)
Risk Assessment Report (based on GAMP 5)
Validation Master Plan (VMP)
Design / Configuration Specification
IQ / OQ / PQ protocols and executed test records
Requirements Traceability Matrix (RTM)
User Acceptance Test (UAT) report
Validation Summary Report (VSR)
SOPs, training records & user manuals
Periodic review and re-validation plan
Validated systems. Trusted records.
Every GxP system that touches a release decision, a calculation, or a regulatory record must be validated. We deliver inspector-ready evidence with minimal disruption to your operations.
21 CFR Part 11 compliance for electronic records & signatures
EU Annex 11 alignment for all computerised systems
GAMP 5 category-based software validation rigour
Risk-based validation aligned with FDA's Computer Software Assurance (CSA) approach,
focusing testing efforts on patient safety, product quality, and data integrity rather than documentation volume
ALCOA+ data integrity controls applied end-to-end
Full traceability matrix from URS to PQ sign-off
Trusted across regulated sectors
Pharmaceuticals
Formulations, OSD, sterile & API plants.
Biotechnology
Vaccines, biologics & cell therapy.
Life Sciences
R&D, QC labs & analytical systems.
Medical Devices
Class I–III device manufacturing.
Consumer & Nutra
Nutraceuticals & FMCG manufacturing.
Agro & Food
Agrochem, food safety & cold chain.