Turnkey GxP Validation
Once you’ve generated a User Requirement Specification, we will work with you to create a comprehensive GxP validation package. It will be completed on-site by our trained engineers who carry out our GxP services.
GxP Validation Package
Supported with RAMS, SOP and software validation workbooks, the GxP validation services package is generated in response to your URS and submitted in a secure PDF format. It is then printed, completed and signed off on-site by our technicians in conjunction with your quality team.
The Functional Design Specification GxP assessment demonstrates whether functional specification outlined in the User Requirement Specification (URS) has been met or surpassed.
The Installation Qualification establishes confidence that the system complies with the functional design specifications and manufacturer’s specification.
The 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 tested) and calibrated for GxP validation.
GxP Validation Support
We offer you support via telephone, email and on-site. If you have any questions about GxP validation, certification or assessment at any stage in the process, please get in touch.
Validated systems installed in accordance with GAMP (FDS, IQ, OQ and PQ) require annual performance qualification (PQ) tests.
Ensure accuracies are maintained with on-site pre and post calibration testing. We provide GxP certification as proof of GxP validation.
Want to find out more?
Please send us an email with details of your requirements or pick up the phone!