Controlled Substance Inventory Management & Electronic Data Entry
Pharmaceutical companies that handle controlled substances face demanding regulatory requirements from the Drug Enforcement Agency (DEA). The DEA requires all records to be accurate and “readily retrievable” on demand. When you factor in the complexity of multiple registrations, sites, and controlled substance locations, visibility into the products from cradle to grave is a mandatory requirement.
Unfortunately, many companies struggle with controlled substance inventory tracking, particularly in sites that combine commercial manufacturing with:
- Research & Development
- Product Development
- Analytical Testing
- Samples for stability, retention, etc
Common problems include:
- Manual, paper-based inventory tracking forms
- Disconnected computer systems (ERP, LIMS, etc.)
- Multiple departmental hand-offs
- Missing Data Required for DEA Reporting
This is why Invistics has developed its Flowlytics(R) software suite, to allow all pharmaceutical companies that handle controlled substances to maintain accurate, real-time electronic inventory tracking.
Controlled Substance Inventory Tracker
The Controlled Substance Inventory Tracker provides real-time visibility the initial purchase or synthesis of Active Pharmaceutical Ingredients (or precursors) all the way through final shipment to the customer (or through third-party destruction). It allows users to gain visibility into the health of current inventory levels as well as customer, process, and purchase orders through intuitive charts and graphs.
The ability to continually monitor current production and movement enables users to immediately address problems as they occur. The software module is customized to the user’s environment and can be configured to provide “alerts” and “goals” for the speed of the inventory traveling through the supply chain. The Controlled Substance Tracker can be configured to “bridge” communication between multiple source systems to provide a holistic view of the entire supply chain. The software is available via the web and can be implemented with minimum resources from IT.
The software is configured to automate the flow of data from multiple source systems such as an Enterprise Resource Planning (ERP) system e.g. SAP, the DEA’s Automation of Reports and Consolidate Order System (ARCOS), as well as third-party market analytics data such as IMS reports. Automation of data minimizes the risk of “copy and paste” errors, provides better visibility to other groups within the company, and answers “what-if” questions may occur in quota applications, e.g., how much additional quota will be required to deliver an increased sales forecast?
Data Vault gives Controlled Substance managers a software tool to enter and track all their transactions (from Issue, to Receive, to Move, to Destruction) into an electronic database that can then be used to populated the Controlled Substance Inventory tracker. It can replace all the headaches and user input errors associated with manual paper-based transactions in R&D, Production Development, and Analytical Labs.
The software can track inventory across multiple DEA registrations and automatically converts controlled substance equivalents from salt to base to other forms. Data vault can also be integrated with reverse distributors, API suppliers, customers, etc. It features a second-person user authorization gate for confirmation, as well as reporting to see the historical movement of transactions by date and type.
The Quota Calculator software helps pharmaceutical companies and their regulatory compliance professionals to shorten the time it takes to prepare initial or supplemental quota requests from the DEA. Compliance Managers may use Quota Calculator to streamline the quota request process, retrieve data from multiple different sources (automatically), to perform quota calculations, and to track the current location and status of quota requests and quota grants in a user-friendly dashboard.
If you’re interested in learning how the Flowlytics may assist your operation, please use the contact form below or call us direct at 1-800-601-3456 to schedule a short phone evaluation.
Contact us about designing a solution for your organization today.