In addition, our systems are fully compliant with FDA 21CFR part 11 and MHRA, CPA, HTA and HFEA regulations and guidance.
Our UKAS ISO 17025 accreditation is testimony to our professionalism.
Our range of systems is manufactured and installed by ourselves within the UK and an overseas distributor.
The ISO 17025 standard is a quality system standard specific to calibration and testing laboratories, demonstrating the capability, competence, accuracy and traceability of the laboratory and its work. The achievement of UKAS accreditation demonstrates Contronics competence to manage and perform the activities defined by its UKAS Schedule of Accreditation. These activities include multi point temperature calibration of temperature sensors and associated wired and wireless loggers within the -90 °C to +125 °C temperature range.
The ISO 9001 approval covers all aspects of our operations. This accreditation is part of our commitment to delivering quality products and services and continuous improvement. The internationally recognised standard covers the hardware and software design processes, the products we manufacture and the on-site services we deliver to our customers.
The in-house engineering team at our premises in Congleton Cheshire designs the hardware and software for our products.
Our field service team carries out the installation, commissioning, annual calibration and validation and routine and emergency maintenance on your system. The Health & Safety of our employees and those affected by our activities is a top priority for us. We demonstrate our Health & Safety competence through our accredited membership of the SAFE Contractor scheme.
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the US's Food and Drug Administration's (FDA) guidelines on using electronic records and electronic signatures. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.
At a high level, Part 11 is a law that ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows any paper records to be replaced by an electronic record, and allows any handwritten signature to be replaced by an electronic one.