Computer system validation

Storing electronic records? Does your laboratory operate to GxP, CLIA, ISO, or other global regulations? If so, you may need to validate your computer systems. Our validation services can enable you to meet global regulatory requirements and help you reduce your compliance risk.

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Experienced support for regulatory compliance

Whether you have limited in-house expertise or you simply want a fixed-price plan to enable you to 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 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?

Industry-standard validation practices performed by our certified representatives. Depending on the service chosen, this can include on-site or remote testing and validation of system requirements to support your compliance needs, including:

  • 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

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 instruments and applications:

Capillary electrophoresis (CE)
  • Applied Biosystems 3500 and 3500xL Genetic Analyzers
  • Applied Biosystems SeqStudio systems
  • Applied Biosystems MicroSEQ ID Microbial Identification Software*
Real-time PCR (qPCR)
  • Applied Biosystems 7500 and 7500 Fast systems
  • Applied Biosystems ViiA 7 system
  • Applied Biosystems QuantStudio 5, 6 Flex, 7 Flex, and 12K Flex systems
  • Applied Biosystems QuantStudio 7 Pro systems
  • Applied Biosystems AccuSEQ Software*
Digital PCR (dPCR)
  • Applied Biosystems QuantStudio Absolute Q system
Flow cytometry
  • Invitrogen Attune NxT Flow Cytometer

* Complete only consulting service

Computer system validation documentation

The computer system validation consulting service develops and produces results in documentation form as tangible evidence, assuring that all software features within the scope of data security, auditing, and e-signature are suitable for intended use. Our CSV offering provides complete or partial consulting services with associated documentation:

  1. Validation plan
  2. Validation risk assessment (RA)
  3. User requirements specification (URS)
  4. System configuration specification (SCS)
  5. Validation test plan
  6. Installation qualification (IQ) with objective evidence
  7. Operational qualification (OQ) with objective evidence
  8. Performance qualification (PQ) with objective evidence
  9. Traceability matrix
  10. FDA 21 CFR Part 11 / Annex 11 / GAMP™ 5 Assessment
  11. Quality assurance review
  12. Validation summary report

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 tiered CVS services to fit varying customer environments and savings on multi-system engagements. If you require further customization for your validation process, or a broader scope of validation services, please contact us at professionalservices@thermofisher.com.

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.

Consulting service options

Resources

For Research Use Only. Not for use in diagnostic procedures.