QAMS Modules- Pick and choose integrated Modules

Change Control:

Change Control Solution helps manage changes within an Organization to be initiated, evaluated and implemented with traceability, tracking and powerful automation. By improving change implementation timelines, reducing scope for human error and unwanted repetitions, the Enterprise is driven towards productivity. Integration of this module into workflows of related CAPA, Deviations, Customer Complaints, Trainings modules and vice versa ensures being flexible, user-friendly and operationally effective.

Deviations and Change Management

Caliber deviation management brings organized and integrated approach for end-to-end deviation management till closure. Availability of quick and clear information, electronic workflow with Task alerts and messaging facilitates timely attention and closure of deviations assuring cGMP compliance. Task escalation mechanism controls the risk of time laps.

CAPA Management

CaliberQAMS has an Integrated CAPA process, which can be initiated from any logical point for all the processes like deviation, change management, Market complaints. With clear task assignment to individuals/groups with target date of closure facilitates close monitoring and on-time closure of CAPA. Grouping and analyzing CAPA action items helps in process improvement and reducing quality issues.  Dynamic escalation process ensures system improvement.

Market Complaints

System offers the capability to integrate and organize customer complaint handling through simple pre-defined configurable workflows. Enhanced team attention and timely involvement of desired personnel helps in taking quicker corrective and preventive actions.

Audit Management

CaliberQAMS helps in managing audits for all departments and process during the calendar year to cover all critical areas of GMP for improved efficiencies. Online logging and tracking of NCs till closure with Alerts and email notifications reduces risk of NCs.It has pre-Configured processes for Internal Audit, Vendor Audit, Regulatory Audit and any other audit process.

Vendor Audits

Vendor Qualification Management solution automates the process of qualifying proposed vendors into approved vendors, tracking approved vendors and managing changes with a web based approach.

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