Regulations, Monitoring, and Documentation

The IDS consistently meets the regulation requirements of sponsors, the FDA, Florida Board of Pharmacy, and other regulatory agencies.

We use SensoScientific^® for temperature monitoring and control and Vestigo^® for protocol-specific pharmacy documentation electronic management, patient enrollment, dispensations, and drug accountability.

The IDS maintains a USP797 cleanroom standards for compounding nonhazardous and hazardous IV drugs. We store all investigational medications within a protocol-assigned bin in its designated control area.

Vestigo^® access

Vestigo^® is a digital, paperless documentation system that allows monitors to conduct remote reviews when given access to pharmacy records.

To gain access to Vestigo^®, review the Vestigo^® Verify Manual. Each time IDS provides access, the monitor receives an email from Vestigo^® with login information. Once access is granted, monitors can click the “View Protocol link” (to the right of the visit notification) to review and conduct the following:

• Protocol – protocol overview
• Inventory – overall inventory and add visit notes
• Returns – patient returns and authorize destruction or return to sponsor
• Documents – shipping invoices, protocols, pharmacy manuals, training documentation, correspondences from sponsor
• Accountability – obtain accountability logs (IDARs)
• Visit Notes – add notes specific to the visit
• Monitor Review – review transactions related to each drug item
• Audit Log – IDS audit trail for review
• Temperature documents – temperature logs and calibration certificates for each drug storage location
• Reports – protocol-specific reports

To accommodate scheduling, IDS maintains a calendar for monitors. Click here to access the site monitor visit schedule. For more information, visit the Vestigo^® Accountability system website.