System/Software Development Life Cycle
From WikiBioPharm
To minimize lower quality software, a well-planned (and executed) Software Development Life Cycle (SDLC) is mandatory. Various models for software development are available, some of which are discussed in this article.
Mnptl 09:32, 1 August 2006 (PDT)
Contents |
Overview
In the context of BioPharma, Software Development Life Cycle is first and foremost an agreement between the Validation, Quality and IT groups. The BioPharma industry is primarily driven by strong ethical and regulatory constraints, whereas the IT industry is driven by rapid change in technology. While both have merits, one cannot underestimate the influence of this culture gap in the development of BioPharma information systems.
Models
Waterfall Model
This is one of the more common models seen in the regulatory environment, usually because it is the easiest to manage from a compliance and documentation viewpoint. We will look at it diagrammatically and then explain how it works, together with its pluses and minuses.
V Model
The V Model was most likely named in reference to the Validation process. It is also often presented as a V-shape documentation workflow.
Simple V Model
[Insert here the simple V Model drawing]
- Project Management.
The first (topmost) layer represents the project management document.
The project starts and stops in this layer.
It states the validation project objectives, the associated risks and the actual outcome.
- User Requirements Specification.
The second layer sets the User Requirements Specification (URS) necessary to meet the objectives and the Performance Qualification Protocol (PQ). The PQ can consist of one or two documents (PQ protocol and PQ Report).
- Functional Requirements Specification.
The third layer sets the Functional Requirements Specification (FRS) necessary to perform the tasks involved in the URS; it also specifies the Operational Qualification Protocol (OQ). The OQ can consist of one or two documents (OQ protocol and oQ Report).
- System Design Specification.
The fourth layer sets the System Design Specification (SDS) necessary to support the FRS; it also specifies the Installation Qualification Protocol (IQ)
Note that so far, the workflow is self sufficient and does not include any technical IT intervention.
Extended V Model
The representation below is an extension of the traditional V Model representing IT's involvement of IT; arrows represent the V Model's logical sequence of events.
