Development Process
All business is process driven. The development of software is no exception. Without a well defined and understood process there can be no guarantee that the software will function as required. In safety critical sectors the need for process is manifest: and is required for regulatory compliance.
We employ process in our work, automated to ensure continued compliance and reduce paperwork.
The software life cycle process we use defines the environment in which development takes place. It affords the opportunity for controlled iterative development, ensuring that experimentation may be carried out without compromising the product's reliability. Perhaps the greatest benefit of this form of development is that development problems and risks are visible for timely review. Thus uncertainties in development may be tackled in a timely fashion before resources are wasted.
A software development process describes the nature of the activities undertaken whilst a product is under development. The process should identify not just types of work, but also the outcome and sequencing of the work. Important aspects will include development of the required documentation that both guides the activities and reports on their progress.
Compliance
Compliance with a process is not simply "red tape". It is an essential part of any quality system to be able to ensure that the work carried out meets expectations. Through the use of a properly structured process the overhead is not onerous: it actually speeds the delivery of products that meet your customers' quality needs. Thus, it helps to ensure a satisfactory and profitable outcome.
To ensure compliance we have developed a process whose provisions may be completely traced to ISO EN-62304. The TraceIT® quality process is available as a product for our customers.
We offer advice and mentoring in the introduction, automation and use of process for regulatory compliance and business improvement.
Our paper on Development Process, which considers this topic in more detail is available on request.
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