Integrated ERP Lot tracking eases compliance and recall issues for pharmaceutical manufacturing

The DEACOM Integrated Accounting and Enterprise Resource Planning (ERP) Software System, produced by Deacom, Inc. integrates lot tracking functionality with all the business processes of a pharmaceutical manufacturer - including purchasing, inventory management, production, sales, formulation, regulatory reporting, and accounting - in a single software system.

"The importance of true lot tracking has never been more apparent," says Deacom President Jay Deakins. "Not only is it necessary for regulatory compliance requirements, but for product recall purposes, as well."

Achieving true lot tracking - where raw materials can be traced seamlessly from receipt through shipment - requires three things, Deakins says: Integrating your business processes in one system, prohibiting negative inventory, and posting transactions in real time.

"If you use multiple software systems to manage your business, you're prone to workarounds and less able to control against errors," he says. "That makes compliance difficult to achieve, and it adds time to the already time-sensitive product recall process."

The DEACOM System integrates all areas of a business in a single ERP software solution to allow pharmaceutical manufacturers to easily maintain process controls. DEACOM can be configured to prohibit negative inventory. Negative inventory and true lot tracking cannot coexist, Deakins says.

"By shipping products that contain items you haven't yet received in your system, you're shipping from fictitious lots," he says. "In a recall, you'd have to spend hours or even days searching original records to try to track those items, and there's no guarantee you'd be able to find all of them."

The DEACOM System helps manufacturers track lots by generating item lot data on bar code labels. Hand-held scanners then record the data in the system and track items in real time as they move through inventory, production, quality control (QC), and shipment. Item history and current status are detailed by date, time, and user in a full lot tracking report.

DEACOM also helps prevent the lot control errors that can cause product recalls. The system's bar code scanners automatically alert users if an item scanned for production doesn't match the batch ticket, thereby preventing accidental substitutions.

Similarly, DEACOM alerts users if inventory has expired so it cannot be used in production. The system allows users to manage multiple expiration dates for the same product, based on different customers' needs.

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