QAMS

CaliberQAMS

CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11 and cGMP regulations. CaliberQAMS helps you in Creation, Review, and Approval of change request, deviation recording, and hence, automating your entire QA process. This results in easy planning, scheduling and executing self-inspections, vendor audits, and regulatory audits. Through an integrated approach, CaliberQAMS facilitates task management of follow-up actions through CAPA and Training.

FEATURES

1. Seamless Integration with Other Systems

   Integrates with other applications by interlocking subsequent process actions like holding a batch due to a deviation, training a team member, or processing a change of document.

2. CAPA

   Plantwise pendency reports with the dashboard to the QA head helps to keep track of incidents and their Corrective Actions and Preventive Actions (CAPA.)

3. Audit Trail

   Actions have audit trails and are certified with electronic signatures.

4. Pick and Choose Integrated Modules

   A highly configurable framework which can mimic and adapt to current processes and improve them is used.

5. Customized Workflows

   Workflows ranging from simple process divisions to complex workflows can be configured.

6. Processes

   Standard processes that can be implemented in CaliberQAMS are Change Control, Deviation, CAPA, Market Complaints, and Internal-External Audit. Other processes can be implemented as well, including Pharmacovigilance, Lab Incident Reporting, and OOS.

7. Tasks & Action Items

   The review, analysis and evaluation workflow can be configured with Quality Assurance (QA), Regulatory Affairs (RA) approvals.

8. Effectiveness Monitoring

   A checklist for effectiveness monitoring can be configured and measured as per the defined frequency.

9. Email Escalations

   CaliberQAMS can notify multiple users of the process about a defined escalation. These escalations are configurable and can be predefined.

10. Reports & Analytics

    CaliberQAMS has a configurable home page with dashboards, analytics, and actionable workflows apart from your own dashboards and reports, ready for decision-making. Reporting engine schedules, generates, and sends various reports to different users.