GxP Validation Services

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

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.

FDS

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

IQ

The Installation Qualification establishes confidence that the system complies with the functional design specifications and manufacturer’s specification.

OQ/PQ Test

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.

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 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.

PQ Tests

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

Calibration Services

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!

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