Change control is a critical component of a quality management system. Regulated organizations are expected to establish a change control procedure as a means of maintaining product quality, safety and assuring FDA and ISO compliance.
QUMAS helps organizations simplify and effectively manage their change control process, extending to product, equipment, facilities and computer system changes. Providing a tool set to automate the change control process of assessment, plan, build, implementation, verification, and close of project, QUMAS facilitates compliance with FDA regulations (21 CFR Parts 210, 820, 600) and ISO standards (9000, 1400, etc.). The result is greater efficiency throughout the organization, more informed decision-making and reduced costs of compliance.
Benefits
QUMAS solutions help to simplify and effectively manage the change control process for organizations:
- Manage all related tasks and actions involved in the change process - track and monitor implementation action items through completion.
- Automated workflow process assigns necessary reviewers and approvers by predefined rules and automatically notifies them of changes and next steps. Related action records are automatically advanced once a change control is approved
- Allow multiple reviewers to perform their approvals in parallel, reducing cycle time
- Preconfigured forms help automate the collection and tracking of data throughout the change control process, assisting in the classification and prioritization of requests. Additional forms may be customized to a user's specific needs and environment
- Link change control records to other quality records, such as CAPAs via parent-child relationships. Reduce data entry and eliminate the errors common to manually transferring information
- Easily search and retrieve documents that can aid in the approvals and decision-making process
- Benefit from a secure, centralized repository for all change control documents
- Enforce a standardized change of control methodology across the enterprise
- Achieve baseline control of the change process