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Efficient and cost-effective CSV solutions for your lab
If it isn’t documented, it can’t be proven—but our CSV service offers the evidence you need. Our comprehensive documentation helps you reduce risk and supports regulatory compliance. Managed by experienced specialists, this service helps you save time and money while helping you keep your electronic data secure and audit-ready.
Whether you lack in-house expertise or want a fixed-price plan to meet regulatory requirements, our CSV service has you covered. Our professionals work closely with your team to help you get into production faster, control validation costs, and manage compliance risk.
Benefits of our on-site Computer System Validation Service include:
- Knowledge and experience: Our team comes with decades of experience in designing, building, testing, and validating our systems, supporting your team's efforts
- Cost control: Our service offers predictable pricing without hidden fees, helping you meet validation requirements affordably
- Current compliance best practices: We stay updated on industry regulations to help you comply with evolving global standards
- Reduced validation time: Our project managers can help validate your systems within weeks, offering quick returns on your investment
Features
Consider the key features of our Computer System Validation (CSV) service:
- Documentation that a computer system meets a set of defined system requirements
- Documentation that focuses on user requirements for the software
- Verification that electronic record-keeping systems are performing to specifications (including accuracy and reliability)
- Provides audit-style template documentation for development and flexibility
- Validation of each system’s ability to identify altered or invalid records
What’s included
This comprehensive document starts with a master validation and ends with a summary report. The Thermo Fisher Scientific Computer System Validation (CSV) consulting service develops and produces results in documentation form as tangible evidence, so that all software features within the scope of data security, auditing, and e-signature are suitable for intended use.
The CSV service offers complete or partial consultations, with 12 industry-standard validation documents and execution for the collection of objective evidence:
- Validation Plan
- Validation Risk Assessment (RA)
- User Requirements Specification (URS)
- System Configuration Specification (SCS)
- Validation test plan
- Installation Qualification (IQ) with objective evidence
- Operational Qualification (OQ) with objective evidence
- Performance Qualification (PQ) with objective evidence
- Traceability matrix
- 21 CFR Part 11 / Annex 11 / GAMP™ 5 Assessment
- Quality assurance review
- Validation summary report
What this means for you
You may achieve a validated state in as little as six months, assisting you in bringing your product to market faster than your competitors. Our streamlined process helps you meet regulatory requirements efficiently, offering you a competitive edge and accelerating your path to success.
Analytics Knowledge Hub
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For Research Use Only. Not for use in diagnostic procedures.