Computerized System Lifecycle
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The computerized system lifecycle is the structured set of activities a GxP system passes through from concept and requirements, through supplier assessment, specification, configuration/coding, verification, and release, to operation, change control, and eventual retirement/decommissioning with data migration. Validation is not a one-time event but a state maintained across this whole lifecycle.
GAMP 5 organizes the lifecycle into concept, project, operation, and retirement phases, with the depth of specification and verification scaled by the system category and risk. Operation is where most of the lifetime is spent: periodic review, backup/restore, security, audit-trail review, and change control keep the validated state intact.
Retirement is frequently mishandled: records must remain readable and complete for their full retention period even after the system is decommissioned, which usually requires validated data migration or a maintained archive rather than simply switching the system off.
- —Phases: concept → project → operation → retirement.
- —Validation is a maintained state, not a single milestone.
- —Operation includes periodic review, backup, security, audit-trail review.
- —Retirement must preserve readable records for the full retention period.
GAMP 5 Second Edition (2022) lifecycle model; EU GMP Annex 11 (2011); 21 CFR Part 11.
Frequently asked questions
What is Computerized System Lifecycle?
The computerized system lifecycle is the structured set of activities a GxP system passes through from concept and requirements, through supplier assessment, specification, configuration/coding, verification, and release, to operation, change control, and eventual retirement/decommissioning with data migration. Validation is not a one-time event but a state maintained across this whole lifecycle.
Which regulations cover Computerized System Lifecycle?
GAMP 5 Second Edition (2022) lifecycle model; EU GMP Annex 11 (2011); 21 CFR Part 11.