Synergistix Sample Accountability Services make it simple to provide full support for sample reconciliation and regulatory compliance monitoring – so it’s easier than ever to address PDMA compliance and other state and federal regulations.
Featured sample management compliance functionality includes the ability to:
- Complete reconciliations
- Perform signature audits
- Coordinate storage unit closeouts and audits
- Enter adjustments
- Monitor and correct exceptions
- Manage SOP and business processes
By supporting the reporting of a captured electronic signature, our CATS Software Suite is fully compliant with FDA/PDMA regulations. Additionally, calls can be captured without an electronic signature by using an external paper process and entering the HCP information into the system. This method allows the paper and electronic records to be associated and tracked together for easy reconciliation.