Tackling Change Management Issues
Our client, a leading company with good turnover and huge production with multiple plants, was facing challenges with the documentation of the quality management activities like change management, deviation management, complaints management, and CAPA management related to all the departments of the plant.
- Change management was done manually and sent to QA personnel for the review of the change.
- QA approved the change, proposed some action plans and defined CFT departments for the review of other departments manually. These action plans were not tracked properly in the manual procedure.
- QA personnel approved or rejected the change implementation and allotted a number to proceed further for the necessary action plans as per the change proposed.
- Manual documentation of tracking of the changing controls initiated was hectic and time-consuming.
- Multiple changes were initiated at a time related to each department without proper tracking leading to data integrity issues and duplication of copies of the same change initiated.
- Separate excel sheet tracking was maintained pertaining to approved changes, the status of the change initiated, related action plans which were quite cumbersome.
CaliberQAMS was implemented after a thorough requirement study was done for all the GMP document management.
• Implemented standard version to cover all QMS activities in a single plant – Plant1.
• Documentation at the plant is completely automated for monitoring from change initiation to approval, CFT departments impact calculation until the closure of the change implemented.
Critical processes automated:
- Complete change control initiation with respect to each department is being monitored and recorded in the system.
- Control approval and number generation is automated along with the CFT dept selection and action plan proposition.
- The easy to use, understand and learn, object modeling based Caliber QAMS system, helps in reducing user and system admin training cost.
- The multi-tier validated framework architecture reduces the time taken to go live.
- The freely configurable template-based CAPA action plans help in reducing planning time and increasing compliance with the desired regulatory monitoring process.
- Seamless integration with SAP helps in attaining an integrated quality approach and reduction of human errors.
- Document change control and dossier with track-change review and approval workflow aids in making precise changes and tracking the changes that are being executed.
- Helps in quickest implementation, reduction in the efforts involved in re-engineering and re-writing the procedures at the time of going live.