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Validated Systems

Service Info
 

C&C Group has many years of experience in developing, managing, and hosting validated systems.  Validated systems are software solutions that meet the highest regulatory standards.

Within C&C Group’s pharmaceutical practise, validated systems frequently relate to patient safety and are used by our clients to monitor persons with life changing illnesses, who require regular medication. The data stored and processed by these applications has to be 100% accurate as any failure could pose risk to a patient’s health and wellbeing.

C&C Group design, develop, manage and host validated systems, adhering to the Validated Model (V-MODEL) for GxP software.

C&C Group’s quality procedures ensure that all validated system software and documentation meets GxP standards.  Annual external and internal audits are undertaken to provide assurance.

The development process required for an automated system will follow the V-MODEL. The diagram below shows how the three main qualification activities are linked to the design process.  It details each stakeholder’s responsibilities, deliverables and core tasks involved with the delivery of a new automated system or the upgrade of an existing automated system.

V-MODEL

 
Benefits
 

The benefits of a validated system cannot be overstated.  When patient safety, quality, stability and reliability cannot be comprised, C&C Group can produce software to fulfil your requirements whilst meeting strict regulatory requirements.

 
Case Studies
 

C&C Group’s flagship validated system development is known as eCPMS (Electronic Clozaril Patient Monitoring System).  This system supports healthcare professionals who monitor the wellbeing of patients suffering from treatment resistant schizophrenia.  The system is deployed throughout the NHS, allowing point of care haematology results to be processed for dispensing decisions within 120 seconds.