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!
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.
Take a step towards Quality Assurance Management, free from the Risk of Non-compliances.
CaliberQAMS is a holistic and scalable solution that can be integrated with applications like ERP, LIMS, Training Management System, and Document Management System.
It facilitates the corporate / quality managers the real-time monitoring of quality incidents at every stage, with integrated dashboard and graphical views for pending tasks, completed tasks, personnel involved, time frames.
CaliberQAMS is a highly configurable framework which can mimic and adapt to your current process and improve it. It can be implemented as an independent application or part of CaliberQAMS or into the portal for integrated solution.
Customized workflows – from simple process divisions to complex workflows, from Initiate to Investigate and to Plan & Close – can be configured. One can configure formats with restricted access to the portion of the format to a group and create an escalation matrix. It has configurable home page with dashboards, analytics and actionable workflows and your own dashboards and reports.
There are more than 200 reports to help you to track and make informed decisions and to give an enterprise and plant wide view. There are drill down dashboards for all levels in the organisation like dashboards for CQA, plant managers,QA &QC heads to veiw deviations,change controls from all locations and drill-down to last detail of incident; Perato chart, a very useful chart which tell you the cause of the incident ( human errors, negligence or equipment failure) and helps to get to robust preventive action;Plant wise pendency reports with dashboard to the QA head helps to keep track of incidents and their CAPA.
CaliberQAMS is a solution with highly configurable, workflow-driven process automation which is 21CFR Part 11 and cGMP compliant. Its helps you in creation, review and approval of change request, deviation recording, automating the 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. It reduces training needs and process changes through a unique process of addressing configuration needs.
Seamless integration with LIMS,Document Management System,SAP,Training Management System