Trust your computerized system validation to the company that designs and supports your system.
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.
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:
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:
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.
Computer System Validation is available for the following instruments and applications:
|Capillary electrophoresis (CE)|
|Real-time PCR (qPCR)|
|Digital PCR (dPCR)|
* Complete only consulting service
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:
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 firstname.lastname@example.org.
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.
For Research Use Only. Not for use in diagnostic procedures.