Change Management Tools

Both aspects of change control essentially are founded upon two databases:

• a change database, which contains details of the change requests through their lifecycles
• a version database, which maintains the evolution of all changed documents.

In regulated industries, such as the Medical Device sector, a regulator may reasonably expect to be able to review the history of a product to determine how it reached a particular condition. Responsible individuals must be identifiable.

Sound change control systems therefore support both comprehensive Audit Trailing and Electronic signatures to ensure that machine records are maintained reliably. We currently use IBM Rational's Clear Case LT and Clear Quest for these activities. We provide our customers with deployment assistance through customisation and the use of bespoke scripting.

We have developed our own customisations for Clear Quest. These help us to manage our own work, ensuring that all activities are completed. They help bind the activities to specific changes in source materials. Above all they provide a customer interface into development, by enabling problem reporting and communication of information. Customers who use our TraceIT® software employ our customisations for accessing our download area and for licence management.