Batch Record Review/Release Software
TrackWise can be used to support batch record review and release functionality for companies both large and small.
For example:
- For companies that have not implemented an ERP system, TrackWise can be used to centrally manage the workflow for the review and release of batches and to ensure all sign-offs are stored electronically, even if the batch records themselves are on paper.
- For companies with an ERP system in place, TrackWise enables automated placement and removal of hold notices to ensure real-time visibility of issues and status.
TrackWise batch record review and release functionality can be seamlessly integrated with other enterprise applications such as document management software (DMS), enterprise resource planning (ERP) systems and laboratory information management solutions (LIMS). Click here to learn more about integration using TrackWise web services.
Benefits:
- Facilitate compliance with pharmaceutical and biotech industry regulations including ISO 9001 and 14001; 21 CFR parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards
- Decrease product time-to-market by improving batch release process efficiency
- Minimize the risk of lost or incomplete data through closed-loop batch record management tracking
- Gain legal protection with complete documentation of batch record management processes
- Provide both flexibility and control with fully configurable batch record review and release process workflows
- Increase accountability though batch record review and release process assignments, approvals and audit trails
- Increase operational transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive overviews