Quality Basics: QMS provides a preconfigured environment for managing changes to and deviations from established quality processes.
The following functionality is included in Quality Basics: QMS:
- Change Controls: Allows you to document desired improvements or changes to existing systems, equipment, procedures, or methods, assess the potential impact of changes, capture the actions required to implement the change, and assess the effectiveness of the change after implementation.
- Deviations: Allows you to track unplanned variances from established procedures, investigate the cause and impact, determine how to address the issue, and track the effectiveness of the corrective and preventive actions.
- Standalone CAPA: Allows you to create records that help you track and manage changes to your site’s controlled processes, and make improvements to products, services, or processes through changes that occur incrementally or all at once.