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 use IBM-Rational's Clear Case LT and Clear Quest for these activities. Our paper on Change Management, which explores them in more detail and includes introductory assistance in their application, is available on request. We provide our customers with deployment assistance through customisation and the use of bespoke scripting.