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:

  1. Concept
    During the concept stage, requirements for the business process that needs to be automated are developed and potential solutions are considered.
  2. 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
  3. 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
  4. 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.