changecontrolled

Changecontrolled is an adjective used to describe items, processes, or documents that are governed by a formal change control process. When something is changecontrolled, it is managed in a controlled, auditable way to ensure changes are properly proposed, reviewed, approved, implemented, and documented, with an established baseline and traceable history of modifications.

Context and use

Change control is widely applied in regulated industries such as pharmaceuticals, medical devices, manufacturing, and information technology, as well as in project and configuration management. The concept emphasizes that any modification could affect quality, safety, compliance, or performance, and therefore requires formal oversight.

Typical process

- Initiation: a change request is raised describing the proposed modification and its rationale.

- Assessment: impact, risk, cost, schedule, and resource implications are evaluated.

- Approval: a change advisory board or designated authority reviews and approves or rejects the request.

- Planning: implementation steps, rollback plans, testing requirements, and validation activities are prepared.

- Implementation: the change is carried out in a controlled manner.

- Validation and testing: the change is verified to meet requirements and to not adversely affect related systems.

- Documentation and closure: all actions are recorded in a change log and version control system; the change is formally closed after review.

Types and safeguards

Standard (pre-approved, low risk), minor, major, and emergency changes describe varying levels of oversight and speed. Change-controlled items typically have versioning, baselining, and audit trails to support accountability and regulatory compliance.

Benefits and challenges

Benefits include improved traceability, better risk management, and compliance with standards such as ISO 9001 or GMP. Challenges include potential delays and administrative overhead, requiring clear roles and scalable processes.

Examples

Software feature updates, SOP revisions, equipment reconfiguration, or infrastructure changes in a data center can be changecontrolled to ensure controlled, documented execution.