The system development life cycle, also known as SDLC is provided by ISPE GAMP 5. This overall lifecycle model establishes a clear overview of all the validation stages.
The four stages of the system development life cycle are:
- Concept
During the concept stage, requirements for the business process that needs to be automated are developed and potential solutions are considered. - Project
The project stage consists of several different steps, including the creation of various documents:
• Planning: qualification plan
• Supplier assessment and selection: vendor assessment documentation
• Definition of specifications: hardware design specification; software design specification
• Configuration or coding: configuration specification; functional specification; source code review and development testing documentation (Cat. 5)
• Qualification: traceability matrix (specifications, tests); factory acceptance testing, site acceptance testing; installation qualification, operational qualification, performance qualification (or installation qualification and user acceptance testing); qualification summary report; system documentation index
• Release for operation - Operation
During the operation stage, the system is used for its intended purpose. Procedures must be kept in place to keep the system in a validated state.
Typical deliverables are:
• System use procedure, system administration (security) procedure, deviation and/or incident management procedure
• Periodic review procedure
• Training procedure
• Backup and restore procedure
• Archiving procedure
• Business continuity plan
• Disaster recovery plan - Retirement
During the retirement stage, the system is decommissioned and data is archived, and a retirement plan and report are created if applicable.
The lifecycle is effectively the same as for classical equipment without computerised components.
