Wayahead Systems: The Manufacturing Integrity Chaperone

Hippocrates once famously said, “Let thy food be thy medicine, and thy medicine be thy food.” This correlation between food and medicine goes well beyond a health-oriented Mediterranean cuisine—it forms an underlying principle of integrity beneath pharmaceutical and nutritional food manufacturing. The 21CFR11 standards that went live in 1997 may be viewed as a cost center in these industries, but one company provides turnkey solutions that help their customers identify and systematically capitalize on value realization in the integrity checks that are defined by the standards. Sydney-based Wayahead Systems offers a comprehensive set of tools under their 3WS product to guarantee integrity during each processing step, and hence the final product of manufacturing.

3WS meticulously performs integrity checks and audit trials throughout the cycle, from barcode label printing, all the way through picking ingredients, weighing, bag counting, mixing, blending, and packaging. The detailed scrutiny from raw materials to end product not only serves the purpose of adhering to FDA regulations for their customers, but also ensures brand integrity on the consumer end.

The system maintains an all-encompassing electronic batch record (EBR), requiring the attention of a single operator, as opposed to the several needed to perform painstaking hand written manual checks. 3WS also records for each activity and authorization, the operator, date and time stamps, location, warnings/errors, and electronic signatures that are used throughout the system.

Among several modules offered for integrity checks during individual processes, the dispensing, weighing, and blending stages form crucial components of 3WS.

We have had a quality process in place ever since 3WS rolled out in 1995, which powers our customer retention

When a production order is created, 3WS scans the material to be used, checks the material against expected ingredient quality and quantity, with an acceptable expiry date. Some other tests for potency and strength factoring are performed on an approved lot. The entire set of tools and features available in 3WS, can be individually switched on or off. Validation checks are then carried out on the features which are switched on. This ability drives superior flexibility of operations for the manufacturer.

During the weighing stage, electronic balances are read for gross and net weights, recording the data within the system. To enable cross-verification during the blending stage, previously weighed data can be printed and scanned later. Wayahead integrates their solution with Programmable Logic Control (PLC) systems to match the lot about to be blended. The system also integrates with major ERP platforms, increasing the capabilities and control given to the operator over the entire manufacturing integrity verification process.

Using this ability, Wyeth Nutrition, recently acquired by Nestlé SA, moved from a JDE system to SAP across four of their sites in China, Singapore, Philippines, and Ireland. By rewriting the collecting interfaces with the SAP ERP platform, Wayahead ensured that no disruption was experienced in the usage of 3WS onsite, due to this major ERP transition. Wyeth currently uses 3WS to label materials, weigh, bag-count, and mix/blend all orders, throughout the year, across four countries. Also, 3WS checks their finished product label claims, for minerals and vitamins, to guarantee product integrity to their consumers.

Wayahead is currently working on making 3WS web-based and interoperable, with flexibility in hosting across the globe. 3WS already manages Active Directory logins and virtual file servers efficiently. Further, a dashboard with an advanced form of enquiries and analytics will be available at a senior management level for customers early next year. “We have had a quality process in place ever since 3WS was rolled out in 1995 and that powers our customer retention,” says John Nesbitt, Director of Wayahead. “These 20 years of experience have put us ‘way ahead’ of the competition.”