Turnkey GxP Validation
The starting point in the GxP process is the generation of a User Requirement Specification. Utilise our online template to generate one and we will work with you to create a comprehensive validation package that will be completed on-site by our trained engineers.
GxP validation package
Supported with RAMS, SOP and software validation workbooks, the GxP package is generated in response to your URS and submitted in a secure PDF format before being printed and completed and signed off on-site by our technicians in conjunction with your quality team.
Functional Design Specification demonstrates the functional specification outlined in the User Requirement Specification (URS) has been met or surpassed.
Installation Qualification, established confidence that the system complies with the functional design specification and manufacturers specification.
Operational and Performance Qualification establishes the required operational configuration and limits are in place and are tested to verify the robustness of the installed system.
Service License and Technical Agreements
SLA and TA are customised to ensure an appropriate level of support and care is in place to guarantee you are compliant with GxP, MHRA and FDA regulatory guidelines. Users of the system have a clear line of support and the hardware is routinely checked (PQ) and calibrated.
Available to you via telephone, email and onsite
Validated systems installed in accordance with GAMP (FDS, IQ, OQ and PQ) require annual performance qualification tests
Ensure accuracies are maintained with on-site pre and post calibration testing and certification.
Want to find out more?
Please send us an email with details of your requirements or pick up the phone!