Before I proceed, I would like to mention that ‘Life cycle’ is different from ‘Process Models’.
The deliverables you have mentioned are outputs from the different phases of a ‘process Model’ for a ‘Product Audit’.
In keeping with the statement you mentioned earlier “This software application is now being sold to the Life Cycle industry
and in terms of passing an audit they need all of the supporting documentation necessary to do so”.
There are no specific process models (V-model, waterfall, RUP, prototyping, spiral, Agile etc…) required, to meet regulatory standards
but rather you need to have a sound Life cycle model to meet regulatory standard and to pass an audit. Life cycle usually may be grouped into three major phases namely:
In pharma or other industry, auditing reviews many areas besides the product. Generally, Auditing may involve three types of area.
- Process audit
- Product audit
- System audit
So to pass/meet/exceed an audit you will need to show holistic conformance in all areas of the audit. The first thing I suggest is a
wriiten Software Quality Assurance Plan (SQA). This plan may be in line with IEEE 730-2002 with the following high level sections:
standards, practices, Conventions and metrics
Problem reporting and Corrective action
Tools, techniques and methodologies
Records collection, maintenence and retention
SQA change procedure and history
(additional sections may be added as necessary)
This SQA plan covers the three main areas of a life cycle and audit areas.
Once an SQA plan is in place you may then proceed to produce the specific documents for the product, which you have mentioned.
I have included an pdf article to help you on software stds. I also included an article i found online on pros and cons of the different process models e.g waterfall etc.
I hope I have helped to answer your question.
Guide to Software standards.pdf (134.5 KB)
software linearity1.pdf (290.4 KB)