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Core Platform Module

Change Control & CCB Matrix Governance

Impact-Driven Change Management with Multi-Disciplinary CCB Approval Routing

Govern process, equipment, facility, and software changes without bureaucratic paralysis. QMSdesk enforces mandatory cross-functional impact assessments (Quality, Regulatory, Validation, Safety, Cost) and risk-based Change Control Board routing.

FDA QMSR (21 CFR 820)ISO 13485:2016 §7.3ICH Q10 Change ManagementEU GMP Annex 15GAMP 5 Cat 5

Key Capabilities & Functional Architecture

01

Cross-Functional Impact Scoring

Standardized evaluation of regulatory notification triggers (e.g. FDA 510(k) or PMA supplement needs).

02

Risk-Based CCB Routing

Low-impact changes route to QA specialists, while High-impact modifications mandate full CCB electronic sign-offs.

03

Implementation Task Tracking

Disaggregates approved changes into discrete child tasks with owners, due dates, and evidence attachments.

04

Post-Implementation Verification

Validates that the change achieved its intended outcome without causing unintended process deviations.

Built-In GxP Safeguards

Segregation of Duties blocks change initiators from acting as sole change approvers.

Changes can be placed ON_HOLD or REJECTED with permanent audit justification.

See Change Control & CCB Matrix Governance in Action

Experience our 15-minute onboarding curve and turnkey GxP workflows with a live 1-on-1 walkthrough.