GxP Validation Support

Get GxP documentation, routine PQ testing and support agreements designed to deliver a comprehensive validated solution and ensure life cycle compliance.

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.

FDS

Functional Design Specification demonstrates the functional specification outlined in the User Requirement Specification (URS) has been met or surpassed.

IQ

Installation Qualification, established confidence that the system complies with the functional design specification and manufacturers specification.

OQ/PQ

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.

URS online template

The starting point in the GxP process is the generation of a User Requirement Specification. Utilise our online template and we will assist you in creating one…

Make a URS Enquiry

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.

Support

Available to you via telephone, email and onsite

PQ Testing

Validated systems installed in accordance with GAMP (FDS, IQ, OQ and PQ) require annual performance qualification tests

Calibration

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!

Call 01929 459 459 if you just want to talk to somebody