Storing electronic records? Does your laboratory follow global laboratory standards or other recognized best practices? If so, you may need to validate your computer systems. Our validation services can enable you to meet global laboratory requirements and help you reduce your compliance risk.

Experienced support to meet global laboratory standards

Whether you have limited in-house expertise or you simply want a fixed-price plan to help enable you to meet your compliance requirements and maintain data integrity across your systems, 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, ensure the accuracy, consistency, and reliability of your data, and manage your compliance risk.

Benefits of our on-site Computer System Validation Service include:

  • Knowledge and experience—we have a long history of designing, building, testing, and validating our systems in complex laboratory environments
  • Cost control—our service helps deliver 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 verification 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?

Widely used industry 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:

  • Dedicated project management—focused on driving the project from start to finish
  • Experienced validation specialist—understanding of industry-accepted validation process
  • SAE software workflow specialist—knowledge of features and function of the software being validated
  • Experienced CSV specialist—focused on execution of SAE software feature testing in approved validation documentation
  • Pre-form template documentation—flexible to accommodate some customer needs into core documentation

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 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/CytPix Flow Cytometer
Imaging systems
  • Invitrogen iBright imaging systems

* Complete only consulting service

Computer system validation documentation

The computer system validation consulting service develops and produces results in documentation form as tangible evidence, testing that software features within the scope of data security, auditing, and e-signature are suitable for product 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. Documentation to enable 21 CFR Part 11/Annex 11/ GAMP 5 summary
  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 complete this form.

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.