Clinical Audits for Good Clinical Practice (GCP)
Clinical audits evaluate and monitor clinical processes, systems, sites, personnel and vendors for compliance with Good Clinical Practice (GCP). TrackWise software enables companies to ensure all aspects of clinical trials are compliant with GCP regulations. TrackWise provides organizations with a fully electronic, web-based solution that tracks and manages all internal and external clinical audits from initial scheduling to preparation, execution, capture of observations, review and reporting.
TrackWise Clinical Auditing Applications
- Scheduling audits
- Tracking planned audits
- Managing audit preparation
- Defining/maintaining audit questionnaire templates and checklists
- Capturing audit responses/observations offline
- Dynamically adding sections, subsections and questions during offline audit execution
- Importing responses and observations
- Track review and approval of audits
- Generate audit reports at various levels
- Trigger investigations, root cause analysis, CAPA, and effectiveness checks from audit findings
Benefits
- Streamline the clinical audit process by consolidating tracking and management of all internal and external audits into an easily accessible web-based system.
- Increase resource utilization and collaboration by automating workflow processes and providing secure access to related information across multiple audit groups and trials.
- Reduce risk of lost records, incomplete items, and overdue tasks by eliminating paper and tracking items electronically.
- Increase visibility of pending items through on-line reporting and dashboards.
- Reduce administrative costs and duplicate efforts by leveraging TrackWise's 24/7 business rules engine, which automates manual procedures and escalates commitments based on priority, due date, and other criteria.
- Improve the effectiveness of investigator site audits by utilizing on-line inspection checklists and questionnaires and tracking any violations or discrepancies through completion.
- Improve visibility of clinical processes, personnel and vendor issues and streamline the audit reporting process for clinical trials.