We use DOORS® (produced by Telelogic AB) to manage customers' specifications. Requirements are initially captured using best practice templates. These are exported from Microsoft Word® to DOORS to create a working document.
We create links between items in DOORS to prove completeness of the specifications and allow change to be managed. We use DOORS in tandem with Telelogic Rhapsody to provide links to external entities, such as design elements in models. The tracing thus afforded allows built in compliance with medical device regulations.
We can customise DOORS to client's needs. By integrating DOORS with a change management system we enable the controlled evolution of change for engineered products. Our system implements electronic signatures that meet the security requirements of 21 CFR 11, the standard used by the FDA and other regulatory bodies in the US.
Documentation appropriate to a customer's quality system and company style can be produced by exporting the developed specifications to word format.
We help our customers to produce and manage their requirements specifications using DOORS. We use a customer's own DOORS implementation or can provide a paper-based solution with the assurance that the documentation is founded on the accuracy and flexibility allowed by the DOORS database.
Our paper on Requirements, which considers this topic in more detail, is available on request.
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