To ensure the appropriateness and consistency of existing processes, the Annual Product Quality Review is a process required by Pharma GMP.know more
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.
A highly configurable framework which can mimic and adapt to current processes and improve them is used.
The review, analysis and evaluation workflow can be configured with Quality Assurance (QA), Regulatory Affairs (RA) approvals.
Plantwise pendency reports with the dashboard to the QA head helps to keep track of incidents and their Corrective Actions and Preventive Actions (CAPA.)
Workflows ranging from simple process divisions to complex workflows can be configured.
A checklist for effectiveness monitoring can be configured and measured as per the defined frequency.
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.
Actions have audit trails and are certified with electronic signatures.
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.
CaliberQAMS can notify multiple users of the process about a defined escalation. These escalations are configurable and can be predefined.
Implementation of Caliber software has given us better confidence to face regulatory inspections. The execution was systematic, training was excellent, and service… Milan
CaliberBRM stands tall on the issues of Data Integrity & ALCOA, complying to all Regulatory requirements, and is a bliss for QA… JB Chemicals