Plan, assess, approve, implement, and track every change with complete visibility and control.
Connected Change Request Management Across the Quality Lifecycle
OneQMS Change Request Management Software helps pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations manage changes in a controlled and consistent manner.
From change initiation and impact assessment to review, approval, implementation, and post-implementation evaluation, OneQMS provides a centralized system for managing the complete change control lifecycle. Organizations can evaluate proposed changes, identify affected processes and documents, assign responsibilities, establish implementation timelines, and maintain complete traceability throughout the change process.
With configurable workflows, risk and impact assessments, automated task management, electronic approvals, notifications, implementation tracking, and comprehensive audit trails, OneQMS helps quality teams ensure that changes are properly evaluated, authorized, documented, and implemented without compromising product quality or regulatory compliance.
Key Capabilities
Centralized Change Control
Manage proposed changes through a single controlled platform, providing quality teams with visibility into change status, ownership, timelines, and associated activities.
Impact and Risk Assessment
Evaluate how a proposed change may affect quality, operations, products, processes, systems, documentation, and regulatory commitments before implementation begins.
Controlled Review and Approval
Route change requests through predefined review and approval stages based on the change type, risk level, and organizational requirements, ensuring changes are authorized before implementation.
Implementation Management
Coordinate all activities required to introduce an approved change, including task assignment, responsibility tracking, target dates, supporting documentation, and implementation status.
Document and Process Traceability
Maintain relationships between change requests and affected quality records, procedures, documents, processes, and other controlled elements to provide a clear history of what changed and why.
Regulatory Compliance & Inspection Readiness
Support controlled change management processes aligned with Good Manufacturing Practice, Good Practice requirements, FDA 21 CFR Part 11, and EU Annex 11, while maintaining documented assessments, approvals, implementation records, and complete change history for regulatory inspections.
Key Features
End to End Change Request Management
Manage change requests from initiation and evaluation through approval, implementation, verification, and closure.
Change Impact Assessment
Evaluate the potential effect of proposed changes on products, processes, systems, documents, equipment, facilities, and regulatory requirements.
Risk Based Change Evaluation
Assess the risks associated with proposed changes and determine appropriate controls, actions, and approval requirements.
Change Categorization
Classify changes according to their type, scope, significance, and potential impact to support appropriate review and decision-making.
Configurable Change Control Workflows
Configure review, assessment, approval, implementation, and closure workflows based on organizational procedures.
Action and Implementation Tracking
Create, assign, prioritize, and monitor implementation activities with defined owners and target dates.
Automated Notifications and Escalations
Keep responsible teams informed about pending reviews, upcoming deadlines, and overdue change activities.
Electronic Review and Approval
Facilitate controlled electronic reviews and approvals while maintaining accountability throughout the change lifecycle.
Implementation Verification
Document implementation outcomes and verify that approved changes have been successfully introduced as intended.
Complete Audit Trail
Maintain a detailed history of change requests, assessments, decisions, approvals, actions, and modifications for full traceability.