An increasing number of industries now require companies to implement some form of track and trace. The pharma industry is no exception. In fact, 70% of global medicine will be covered by some form of track and trace system by 2017. By 2023, regulation will require every medicine packaging to be traceable back to the original manufacturer.
The latest ERP software makes it feasible for pharma companies to meet the increasingly stringent requirements and UDI regulations.
UDI compliance at a glance
UDI regulations are enforced by the FDA. It is in effect in the US, with the EU and other countries expected to follow suit to make UDI a global standard.
The US FDA UDI regulation was enacted in September 2013. It establishes a uniform identification system for labeling and identifying all medical devices. This is done by assigning each device a unique device identifier number.
The goal is to prevent counterfeit products and implement a national standard to prevent drug and medical supply chains from getting entangled in conflicting state laws.
Enter track and trace software
Most modern ERP software provides a seamless exchange of gap-free automatic data flow between the ERP system and production line. Pharma companies can easily track and report all orders and serial numbers – right from the shop floor office. This drastically cuts down on downtime, not to mention it also meets the federal track and trace regulations of aggregation and serialization.
ERP software streamlines track and trace by automating tasks in these three areas:
1. Order Preparation
All orders can be entered directly into the ERP system. Subsequent orders can also be completed at the office or even automated, as opposed to being executed in the labeling system or production line itself.
ERP software manages all identification-related processes. It monitors the entire lifecycle of the product as it is funneled through a complex pharmaceutical supply chain. Along the way, the system looks for deviations, such as contamination or mislabeling.
Production managers can pre-set the system to respond in a specific manner when a deviation is detected. If a new order is missing a serial number or two, for example, the system can be set to automatically send a notification to the appropriate department requesting more serial numbers.
ERP systems assess the data and create reports about the products and their corresponding serial numbers. Reports include full analytics that can be exported to excel. This provides organized documents that can supplement annual product reviews and pharmacovigilance reports.
Meeting UDI compliance with NexTec
There is no scurrying around the regulatory compliance for the pharmaceutical industry. NexTec works with pharma companies to use ERP to facilitate the flow of information within the organization between departments such as finance, human resources, and manufacturing/supply chain management. We find the right solutions and configuration for your unique organization that will automate functions like ordering, monitoring, and reporting – all while complying with the latest compliance regulations and UDI provisions. NexTec has expertise in various cloud-based, ERP and CRM systems, including Microsoft Dynamics, Acumatica, Sage, and more. Contact us using the form at the right to learn more.