Global Compliance offers a comprehensive suite of services to facilitate compliance with FDA regulations and PDMA legislation as well as your corporate policies and procedures specific to prescription drug samples, facilities, and other corporate equipment and property.

Services

• Annual sample accountability inventories - yearly inventories that include hard copy or electronic inventory,* sample storage facility inspection, and cursory documentation review.
• Random inventories or audits - randomly conducted inventories of select sales representatives in desired number and frequency; standard procedures are the same as for annual sample accountability inventory services.
• Client-provided list
• Automated random selections by Global Compliance inventory system to mitigate risk of unfair selection claims
• For-cause inventories - inventory, storage facility inspection, and cursory documentation reviews for representatives who may be suspected of diversion or policy violations.
• For-cause audits - detailed investigations on a case-by-case basis for representatives suspected of violations with PDMA and/or corporate policies.
• Physician office visits - reviews performed independently or used in conjunction with for-cause audits to validate that the sales representative supplied samples as documented and verify physician's signature on the sample drop card.
• Closeout inventories and property collection - management of inventory, collection, and transfer of product samples, vehicles, electronic equipment, promotional items, credit cards, and other company property within a signed chain of custody process conducted when a representative is leaving the company or leaving their sampling position.
• Fleet inspections - verification of a representative's assignment to a specific company vehicle, inspection of the physical condition of the vehicle, and validation of license, registration, and insurance coverage.
• Warehouse inspections - examination of warehouse facilities to verify inventory, security, proper storage, labeling, and shipping/receiving procedures.
• New storage location inspections - examination conducted on proposed storage areas prior to new representatives receiving an inventory shipment in order to ensure a safe, secure, and compliant environment.
  * Electronic inventory conducted using hand-held scanning device.

Why Global Compliance?

• Geographically distributed network of highly trained and experienced auditors ensures timely and cost-effective inventories and audits across dispersed sales force.
• User-friendly, secure website enables 24-hour, real-time access to information for viewing and tracking of inventory status.
• Administrator management of sales representatives permits updates to contact information and visit status.
• On-line audit scheduling through a user-friendly order request interface simplifies the order process and allows tracking of one-off audits.
• Standard or custom searches enable filtering of program data and output into Excel to allow graphing and charting.
• E-mail notifications advise of audit completions and flag incidents of noncompliance.
• Archiving of audit results allows administrator to identify and separate reports that have been completed and internally reviewed; accessible through search functionality.
• Centralized data repository enables program oversight into multiple campaigns.
• Dedicated Client Service Coordinator manages your campaign design, implementation, and completion and supports ongoing program needs.