Pharmaceutical manufacturing and testing depends on a global supply chain and network of vendors, manufacturers, whole sale and distributors for getting the essential healthcare products to customers, needy patients.

A global track and trace are currently in place in terms of 2-D bar coded, RFID etc. On more granular implementation levels most pharmaceuticals companies depends on ERP systems such as SAP, Oracle, Dynamics etc for inventory management and complex LIMS laboratory information management system for quality control, stability testing and product release.

However drug substance and drug product manufacturing and packaging still rely on decades old ancient process of a paper based system for batch execution and submission for during FDA submissions, audit and inspections. This results in data loss, data manipulation, data integrity and physical requirement to store and retrieve executed batch records.