Automate product manufacturing processes and templates

Protocol Verification

Biopharmaceutical companies typically utilize QDMS systems to manage quality documents. However, the oversight, applicability and standardization of these documents utilizes a number of different excel work sheets. These excel work sheets, in essence contain the same set of data but are used to track different elements and provide different overviews from oversight to status and workload planning. This system is not satisfactory, labor intensive and there is a risk of information not being consistently tracked. In addition, organizations need to produce various reports which currently can only be managed separately and majority are updated manually. Further the lack of integration of these into the business processes makes it difficult to track quality and compliance.

Quartica’s solution can help centralize the tracking and oversight of quality documents for a specific department or across the organization. It will help support the standardized management of core QD data for global and local sub-sites so as to enable the cross-functional exchange of information. It will provide a centralized view of all QDs and their relationships, versions and other quality and compliance attributes. The tool will support the generation of pre-configured report outputs including tracking of workload plans.

Key Features

Global oversight of the quality documents, including planning and communication of updates
Generate pre-configured outputs such as the TOCs, SOP architecture, QD counts and others
Dashboards and metrics to visualize the Global QD Roadmap
Roles based access control to support granular permissions based project roles and teams.
Tracking of dates and activities, enabling collection of metrics and top-down visibility.
Searching, retrieval, navigation, and reporting capability.
Manage Review and Approval workflow process
Collaborate with partners and local affiliates
Ensure conformance to standards, templates and regulations

Benefits

Centralized oversight, planning, tracking and notification of quality documents

Track document status and other quality attributes and generate workload plans

Capture process milestones in order to enable metrics and reporting

Automate generation of dashboards reports and metrics.

Ready to automate your APR business process?

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