Hugely challenged by change management complexities and multiple, tightly inter-connected implementation practices like CAPA, Audit and training?
Facing difficulty in preparing Annual Product Reviews (APRs) and Analyzing Trends to arrive at Risk Priority Number (RPN)?
Tired of tedious process management of self-inspection: planning, scheduling and tracking non-conformances till their logical closure?
Arm yourself with CaliberQAMS and
Face your QA Challenges Boldly and Victoriously!
Quality Assurance Management System
CaliberQAMS offers you a highly configurable, workflow driven process automation with 21CFR Part 11 and cGMP compliance. Its unique process of addressing the configuration needs makes it quick to implement, mimicking the current formats and workflow, thereby reducing training needs and process changes. Pre-validated central framework reduces validation efforts during and after its implementation.
CaliberQAMS allows you to set your standards and formats to ensure authentic quality assurance efforts, and demonstrable compliance to regulatory norms. All the important actions are subjected to audit trails and certified with electronic signatures. It affords Management of Deviations and Changes, Audits, Market Complaints, and Corrective Actions & Preventive Actions (CAPA), including the pointing of reasons and the needs, if any, for re-training for the persons involved.
CaliberQAMS ensures strict administration with access control and accountability of the System users and facilitates registration of authentic forms with approved templates. Its Issue Manager assists you in dealing with various daunting tasks with ease, authenticity and complete traceability, with 21CFR Part11 compliance and adherence to various Good Practices including cGMP.
CaliberQAMS allows you to draw schedules of tasks, and follows up with timely alerts to concerned persons. It won’t allow sidestepping of important subtasks or unauthorized circumventing of approved procedures, from Initiation to final Closure, of any Issue or scheduled task or action. This helps in orderly and timely resolution of issues. Its dynamic dashboard affords you instantaneous status monitoring and its report builder generates the various reports, in the formats you had wanted and defined.
Some of the functionalities and capabilities of CaliberQAMS include the following:
Take a step towards Quality Assurance Management, free from the Risk of Non-compliances.