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.

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

What do you receive with our computer system validation service?

On-site standard validation performed by our certified representatives. This consists of on-site testing and validation of typical system requirements to support your compliance, including:

• Comprehensive user requirements and associated test cases to verify that electronic records are generated, maintained, and archived in an accurate, reliable, and secure manner
• Validation methodology based on GAMP5 guidelines and risk-management practices
• Expedited delivery within two weeks following final document approval

Computer system validation service

• Representatives are trained and certified for Applied Biosystems™ instruments and software
  • Test and validate system requirements over multiple days to demonstrate compliance with GxP regulations and guidances

• Completion of 12 documents and standard Computer System Validation (CSV) IQ/OQ/PQ test cases
• Industry-expert reviewed and approved CSV approach
• Multi-system pricing available
• Expedited delivery

An externally reviewed validation approach

Robert McDowall, PhD, CChem, FRSC, a recognized authority in validation of laboratory data systems, worked with us to develop a comprehensive approach that would help meet global regulatory requirements when validating our software and systems.

Supported software

Computer System Validation is available for the following Applied Biosystems™ software packages:

• SDS Enterprise Edition 2.x Software for 7900HT Fast Real-Time PCR Systems
• SDS v1.4 21 CFR Part 11 Module Software for 7500 and 7500 Fast Real-Time PCR Systems
• SDS v1.5 21 CFR Part 11 Module Software for 7500 Fast Real-Time Systems
• ViiA™ 7 Real-Time PCR System v1.x Software
• 3500 Series Data Collection v1.x Software for 3500/3500xl Genetic Analyzer

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 support

Prerequisites

• Recently qualified or requalified instrument(s)
• SOPs as related to the lab system

Flexible pricing plans

To help you control validation costs, we offer savings on multi-system engagements for on-site validation. If you require further customization for your validation process, or a broader scope of validation services, please contact us at service.sales@thermofisher.com or via telephone at 800 327 3002 (toll-free in US only).

Customer has the sole responsibility to ensure that Thermo Fisher Scientific and/or its affiliate(s) products and services, including but not limited to qualification and validation, are adequate to meet customer’s own regulation, certification and other requirements.

“Request a service quote tailored to your lab’s budget and needs. Visit our Service Selection Tool today to receive a customized quote.”