Your priority is to demonstrate 21CFR part 11 and the latest MHRA compliant monitoring. Our systems and processes are structured to provide the support you need at each stage of the contract to achieve MHRA compliance.
Calibration and System validation
Your system needs to be validated every 12 months. Contronics will provide a regular sensor calibration to an approved SOP ISO 17025 quality standards. Complete end-to-end alarm testing validates the overall system operation.
Specification & Design
A Functional Design Specification (FDS) will be produced in response to your User Requirement Specification (URS), followed by a Factory Acceptance Test (FAT) specification, qualification protocols and Site Acceptance Test (SAT).
Our systems are classified as Commercially available Off-The-Shelf Systems (COTS) systems. The standard system is configured for your specific application. If your requirement demands it, our in-house engineering team will develop additional non-standard hardware and software; modifications to a COTS system offer significant savings in development and validation over a full custom system.
If required, the Factory Acceptance Test (FAT) carried out at our offices demonstrates clause-by-clause compliance with your approved Functional Design Specification (FDS). Your staff, of course, have the option to witness the FAT.
Installation and Training
As part of our installation and commissioning procedure we generate a comprehensive package of IQ and OQ documentation containing everything you need to demonstrate MHRA compliance.
We run on-site training courses for different levels of users. These courses cover all aspects of system operation and we issue training certificates as required by regulatory authorities.
Maintenance agreement and Support
An annual service level agreements which protect your investment in Contronics Laboratory Monitoring Systems. These agreements include scheduled calibration, validation and mapping. We prepare a comprehensive documentation package ready for your annual regulatory inspection. This documentation pack includes UKAS traceable calibration certificates for the test instruments used.
Telephone response - Our applications engineers are available from 8am to 10pm to answer your queries about new applications and system operation/expansion of current installations. A pager service will take your call between 10pm and 8am.
If you have a maintenance contract and the issue cannot be solved over the telephone, we schedule a site visit the following day if your request for assistance is received before twelve o'clock, noon.
Software updates are a result of our continuing product improvement policy; updates are free of charge to clients with maintenance agreements. A Factory Acceptance Test (FAT) plan is produced which covers not only testing of new features but contains aspects of regression testing based on documented risk analysis. Client’s Quality departments may review this plan. A Site Acceptance Test (SAT) will be performed following installation of the software update on the customer's hardware. The SAT is performed by Contronics engineers and witnessed by client’s Quality staff; it validates the new functionality and proves that existing functionally is unaffected by the update and maintains MHRA compliance of your Laboratory Monitoring System.