Development of a Digital Compliance Platform for Controlled Substance Management in Independent Pharmacies

Independent pharmacies lack an integrated digital solution for managing controlled substance inventories, resulting in manual recordkeeping, recording errors, and inefficient audit processes. Pharmacists are responsible for monitoring complex regulatory requirements but lack dedicated tools to automate inventory tracking, generate compliant reports, and perform accurate audits, increasing the risk of noncompliance penalties and operational inefficiencies.

A network of independent pharmacies seeking to streamline controlled substance inventory tracking, regulatory reporting, and compliance audits through a compliant digital platform.

• Design and implement a web-based SaaS platform to facilitate compliant tracking of controlled substance inventory and dispensing activities.
• Automate 90-day compliance audits and biennial DEA inventory reports to reduce manual effort and processing time from hours to minutes.
• Develop integrations with pharmacy management systems to ensure real-time, accurate perpetual inventory tracking and dispense recording.
• Provide digital tools including FDA-compliant reports, audit logs, and tracking dashboards for pharmacists to ensure regulatory compliance.
• Ensure platform scalability and security to support the onboarding of multiple stores and thousands of users while maintaining data integrity and confidentiality.

• Digitized inventory logging and records management to minimize errors.
• Automated generation of schedule-specific reports and audit documentation.
• Automated 90-day audits and biennial DEA inventory reports with minimal manual intervention.
• Multi-system integration capabilities with existing pharmacy management platforms and wholesale suppliers to enable accurate, real-time inventory synchronization.
• Role-based access controls for pharmacists, staff, and auditors.
• Robust tracking of controlled substances outside standard pharmacy management systems to maintain inventory accuracy.
• Audit trail logging for all inventory and system activities.

• Pharmacy management systems to synchronize controlled substance inventory and dispenses
• Wholesaler inventory systems for real-time stock updates
• Regulatory reporting platforms for compliance submission

• System scalability to support over 100 stores and thousands of users
• High availability with 99.9% uptime
• Secure data handling complying with healthcare data regulations
• Audit trail and activity logging for compliance purposes
• Automated report generation within minutes

The platform aims to significantly reduce manual effort in compliance processes, decreasing audit times from hours to minutes. It will improve inventory accuracy through seamless system integrations, mitigate noncompliance risks, and support the expansion of the pharmacy network with reliable, automated compliance reporting, ultimately enhancing operational efficiency and regulatory adherence.