Computer System Validation
Experienced support for regulatory compliance Whether you have limited in-house expertise or you simply want a fixed-price plan to enable you meet your regulatory requirements, our Computer System Validation Service can help you. Our professionals—working closely with your staff—can help you get into production faster, at the same time also allowing you to control validation costs and manage your compliance risk.
Offering a full consultancy package comprising customer briefing, problem analysis, technical research, problem solving, technical implementation and performance validation.
Benefits of our on-site Computer System Validation Service include:
- Knowledge and experience—no one has a longer history of designing, building, testing and validating our systems in complex laboratory environments than us who made them.
- Cost control—our on-site service delivers the support you need to help meet your validation requirements at a predictable price without hidden fees or variable costs
- Current compliance best practices—we constantly update our body of industry "best practices," keeping abreast of regulations so we can help you comply with complex and ever-changing global compliance requirements
- Reduced validation time—our experienced project managers can validate your systems within weeks, helping you achieve quick returns on your investment
Computer system validation deliverables
- Validation plan
- System risk assessment report
- User requirements specification
- System configuration specification
- Test plan
- Installation Qualification (IQ) testing and results
- Operation Qualification (OQ) testing and results
- Performance Qualification (PQ) testing and results
- Optional) Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11)
- Validation traceability matrix
- Quality assurance review
- Validation summary report
- Review of Standard Operating Procedures (SOPs)
- Technical suppo
