Meet FDA Pharmaceutical Serialization Requirements with DEACOM ERP
FREMONT, CA: Deacom, a developer of a single-system Enterprise Resource Planning (ERP) software, provides manufacturers with a solution to achieve various levels of serialization without sacrificing production efficiencies. Specifically, Deacom helps tie together manufacturing equipment with its ERP system to ensure pharmaceutical companies maintain compliant with new regulations put forth by the FDA.
“Regulatory requirements are in constant evolution,” said Scott Deakins, COO, Deacom. “Right now, pharmaceutical companies are focused on serialization at the unit, case, and pallet levels, but tomorrow’s challenge is still unknown. As businesses evaluate options to meet today’s FDA requirements, system flexibility should be top of mind. If the solution cannot react to changes quickly and with minimal disruption, then it will fail to support ongoing shifts in regulatory and industry priorities.”With all features inherent to the main ERP solution, DEACOM can quickly respond to changes in the industry. This flexibility has enabled the development of serialized capabilities beyond the industry standard by strengthening automation and process control in the pharmaceutical industry. Deacom’s serialization features include:
• AutoFinisher –Deacom’s AutoFinisher drives automation for manufactures who need to serialize and label goods at various levels, as well as report on job finishes.
• Unlimited Levels of Serialization–While the FDA is requiring serialization at unit, case, and pallet levels, DEACOM ERP allows for an unlimited number of serialization levels to be implemented.
• Lot Tracking–Once serialization is complete, DEACOM WMS will track inventory in real-time and facilitate future inventory transactions.
• Advanced Shipment Notice (ASN)–DEACOM ERP can automatically create the ASN which includes all serialized data of not just the pallet, but also the cases and units included on it. This document can then be shared electronically with customers and the FDA to enhance recall reporting.
21 CFR Part 11 Compliance – By tracking and storing all information, including commissioned and decommissioned serialized numbers, within DEACOM ERP, manufacturers can maintain 21 CFR Part 11 compliant.