Achieving pharmaceutical drug traceability compliance

Key attributes of an enterprise resource planning (ERP) system required for drug traceability has been published in a Universal Journal of Pharmacy and Pharmacology paper. Specifically, it described how ERP systems clarify every aspect of operations in a business for drug serialisation compliance. The authors highlighted that this is helpful when setting up infrastructure to implement drug track and trace systems.

The paper noted several challenges regarding drug traceability compliance. These included increased process complexity, changing consumer behaviour, healthcare reforms, a rise in the quantity of data without adequate infrastructure to utilise it.

Enhancing drug traceability compliance

An ERP system is a computerised tool that centralises a company’s drug traceability information through full integration via a structured, safe, and accessible format. It facilitates data exchange across all functional divisions both externally and internally in a company.

Ultimately these systems enable drug serialisation compliance by improving efficiency and accuracy to prevent costly errors and delays, according to the paper. Data integrity, process efficiency and more data visibility are therefore possible.

To achieve compliance with numerous federal regulatory authorities, including drug traceability for patient safety, the pharmaceutical industry must implement a systematic procedure in an ERP environment, the paper stated. The goal would be to provide real-time warnings to supply chain stakeholders and regulatory bodies to maximise the benefit of this integration.

The author highlighted research which declared that development of an effective strategy for enterprise systems is “dependent upon the development of acceptable functionality to meet key attributes of a drug traceability system [for counterfeit drugs]. This can be measured by success factors of systems that have been successfully implemented and their interactions.”

ERP systems and drug serialisation

As the scale of generating serialising products is minimal, small manufacturers can alter or improve their current Base ERP system and develop an internal serialisation process. The in-build serialisation program will have a very low sustainability rate and can be integrated with the support of the current ERP system.

Kumar acknowledged that a comprehensive solution for drug serialisation in ERP systems allow drug manufacturers to monitor these metrics and maintain adherence, “due to its customisable interface, centralised networking capabilities, and automated solutions, which allow pharma businesses to keep up with the always changing standards and laws.”