Change Control
What is Change Control?
A formal process for managing changes to systems, processes, and configurations to minimize disruption and maintain system integrity.
Terms that appear alongside change control
Each of these is named in at least one of the same controls as change control. The number is how many controls name both.
- audit 21 shared controls
- configuration management 19 shared controls
- integrity 16 shared controls
- baseline 16 shared controls
- change management 10 shared controls
- audit trail 9 shared controls
- compliance 8 shared controls
- vulnerability 8 shared controls
Frameworks that govern change control
What the standards actually require on change control
Requirements naming change control across 6 standards, quoted from the control text.
Control changes to the baseline configuration through documented requests, approvals, testing, and tracking.
SP800-128-CHANGE-CONTROL · Configuration Change Control →GAMP 5 SUPPLIER ASSESSMENT + OPERATIONAL PHASE + CHANGE CONTROL + PERIODIC REVIEW. SUPPLIER ASSESSMENT: pre-engagement qualification + risk-based depth (lighter for Cat 1/3 + deeper for Cat 4/5);
GAMP5-Supplier-Operations-Change-Periodic · Supplier Assessment, Operational Phase, Change Control and Periodic Review →Configuration change control. Implements CyFun PR.IP-3: configuration change control processes are established and applied.
BE-CF-24 · Configuration change control →GLI-33 audit + logging + security + change + resilience. SIGNIFICANT EVENT LOGGING: every regulatorily significant event must be logged with timestamp (regulator-time-source-synced typically via NTP + Stratum-1) + actor + action + outcome + correlated session/...
GLI33-Audit-Logging-InfoSec-ChangeControl · GLI-33 Audit, Significant Event Logging, Information Security, Change Control, Resilience →Approve changes through documented procedure including impact analysis, verification, and traceability.
IEC62304-8.2 · Change Control →Determines whether changes are proposed, reviewed, approved or rejected, and recorded, and whether implemented changes match what was approved.
171A-03.04.03 · Configuration Change Control →Questions people ask about change control
What is Change Control?
Why is Change Control important for compliance?
Which compliance frameworks address Change Control?
Where can I learn more about Change Control?
See how Change Control applies across compliance frameworks
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