Quality Process Solutions

The TraceIT® quality process has been designed to meet the requirements of software developers who need to demonstrate compliance with standards. Compliance is essential especially in industries in which high integrity is essential.

The TraceIT® quality process has been tailored to meet the needs of compliance with published standards. An example is ISO EN-62304, which is the standard for the lifecycle of development Medical Device software.

We provide a range of options for delivery of the TraceIT® quality process:

• The TraceIT® quality process is available off the shelf and provides you with the documented process linked with the standard to demonstrate compliance. You are provided with the process definition, guidance notes and mentoring templates. The templates help you to ensure that your implementation is in line with your organisation's established procedures. The templates guide you through the technical aspects of the process.
• The Packaged Quality Service provides you with the TraceIT® quality process supplemented by up to 4 days of on-site/telephone mentoring or consultancy.
• The Bespoke Quality Service provides focused consultancy for introducing the TraceIT® quality process to match your business needs. These may include additional staff training and customisation of a Software Development Plan to interface seamlessly with your company's quality system and other procedures.

Please contact us for further details and pricing information about the above packages.

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