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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.
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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…
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.
More about
Our services
Services
Overview
We tailor our services to support our customers' regulatory requirements. We offer calibration, monitoring, environmental compliance, temperature mapping and GxP services. Get quality support to achieve the demands of regulatory requirements.
Services
Temperature Mapping
We work with you to collect thermal stability data and conduct temperature mapping of storage areas, pharmaceutical warehouses, incubators and appliances that are used in controlling temperature within the supply chain. Our temperature mapping services can generate a clear and concise report compliant with relevant legislation.
Services
Calibration
Our calibration services, including temperature & laboratory calibration services, are designed to deliver the best possible accuracies and ensure traceability in compliance with regulatory guidelines. We are a calibration company that will work with you; we can provide our calibration services in our laboratory or on-site at your premises.
Services
Rental
Rent data loggers, temperature mapping packs and validation equipment from Wessex Power. We can support you in performing periodic temperature validation and mapping exercises with no upfront costs or minimum hire period.
Services
Training
Operators of even the most intuitive software utilities and user-friendly instrumentation can benefit from our training courses. Our courses introduce you to what is possible or to implement a configuration in accordance with your standard operating procedures.
Want to find out more?
Please send us an email with details of your requirements or pick up the phone!
