• CaliberQAMS

Dealing with Effectiveness Monitoring Schedule Management Issues

A prominent pharmaceutical company with multiple plants, our client, was facing challenges with the documentation of the quality management activities like deviation management, change management, CAPA management, and complaints management related to all the departments of the plant.

Challenges:

  • Lack of controls on documentation was leading to repetitive errors when the work was done manually.
  • The effectiveness monitoring schedule wasn’t effectively managed due to manual practices and due to human intervention.
  • The sequence of steps that is part of action plan management was a cumbersome exercise when done manually and a few of the action plan items were not even addressed before QA approval.
  • Generating log reports, pendency reports, monthly reports, and establishing an escalation matrix was a herculean task.

Solution:

CaliberQAMS was implemented after a thorough requirement study was done for all the GMP document management.
QAMS structure

  • Implemented a standard version to cover all QMS activities in a single plant.
  • 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 were automated:

  • Complete change management, deviation management, CAPA, Complaint management, and audit management.
  • Control approval and number generation is automated along with the CFT dept selection and action plan proposition.

Benefits:

  • To address the lack of proper controls on documentation and the following sequence of steps issue, we have the facility to channelize the documentation controls department wise and bring validation controls on sequence of steps.
  • While working on deviation management, the availability of information related to the same kind of deviations faced earlier is listed for reference which helps in taking a better decision on the given issue.
  • Drill down reports with multiple filter options are available to manage all kinds of workflows.
  • A group-based and personal based task allocation option is available with Caliber QAMS as a unique feature.
  • Time and effort spent on creating log reports, pendency reports, monthly reports, and establishing an escalation matrix were saved due to complete automation of the process.