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Quality

Founded on quality

The business of Cambridge Cognition has always been founded on quality. We strive for quality in all we do - people, systems, processes, products and services. We believe a focus on quality will improve customer satisfaction, drive business forward and lead to healthier, more sustainable growth.

Quality assurance is an independent division of Cambridge Cognition Limited, reporting directly to the CEO.

Regulatory compliance

The system development lifecycle is controlled with written SOPs to ensure all systems are fully validated. We have strict controls for record and documentation management to ensure that system validation is traceable and available to clients.

All CANTABelect systems are designed to meet the requirements of 21 CFR Part 11 and GCP with a robust audit trail and encryption techniques.

Audits

As part of the quality assurance program, we conduct regular internal audits of all our processes and critical suppliers. Audits are conducted by independent experienced and qualified personnel in computer systems validation and GCP. We are also successfully audited continuously by our clients, prospective clients, regulatory authorities and our ISO accreditation organisation.

Continuous improvement

Audit findings as well as other issues and risks are fed into the CAPA (Corrective and Preventive Actions) system, tracked, presented at management review meetings and followed through resolution, to ensure continuous development.

Customer satisfaction

Our aim is to achieve 100% customer satisfaction in every aspect of our services. We welcome - and indeed, actively seek - feedback of any kind from all of our clients. This is valuable to us and often provides the drive for ongoing improvements to our products. You can leave feedback for clinical trials or academic research.

If you are unsatisfied with any of our products or services, or wish to report issues relating to regulatory compliance or to request an audit, please contact our Quality team directly.

Certification

Cambridge Cognition's Quality Management System is integrated with GCP and it is primarily designed for the continuing delivery of excellence to you, our customers. Cambridge Cognition staff are qualified and undergo regular training in GCP, 21 CFR Part 11, principles of validation and GAMP.

Cambridge Cognition Limited first received ISO certification in 2006 and is currently certified to ISO 9001:2008 + TickIT (view certificate).

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