Encapsulating Efficiency: Compliance and Efficiency at Proteus Digital Health
Real-time data used to rapidly identify and investigate production roadblocks
Errors associated with manual data entry reduced
Occurrence of paper on the shop floor reduced
Ease-of-customization with TrakSYS was critical for us as our manufacturing operations encompass very different activities within wafer processing, sensor production, and tablet compression. However, the ultimate deciding factor was Parsec's professionalism and integrity. They integrated with us as an extension of our own team through design, development, training, documentation, and validation until we successfully cut over from paper-based processes to TrakSYS.
The Company
Armed with more than 500 issued patents and led by some of the brightest minds in technology, pharmaceuticals, and healthcare, Proteus Digital Health invented Digital Medicine, a new category of pharmaceuticals that measures medication treatment effectiveness, helps physicians improve clinical outcomes, and helps patients reach their health goals.
The Challenge
Proteus' proprietary sensor contains tiny amounts of magnesium and copper that, when ingested, combine to create a reaction sending a wireless signal to a battery-operated patch worn on the patient's abdomen. As clinical trials entered their final stages and demand for the product began to grow, the team at Proteus realized they needed a MOM platform to help meet regulatory requirements, create audit-ready traceability, and optimize production.
Manufacturing the sensors is complex, involving many processes over an extended period of time. As production volumes grew, stringent regulatory requirements, paper records, siloed data, and long, multi-phased production cycles became increasingly burdensome.
The Solution
To streamline operations and digitize record-keeping, the team at Proteus worked alongside Parsec Automation, LLC to architect a TrakSYS solution. The rollout was designed to help users manage production routings and enforce workflows to achieve regulatory compliance, improve the accuracy of data collection, and eliminate paper-based record keeping. The team integrated TrakSYS with production equipment, barcode scanners, labelers, and existing PLCs.
Working alongside Parsec, the team at Proteus Digital Health designed a TrakSYS rollout that would eliminate paper records for all wafer production, reduce errors related to nonconforming material reports (NCMR), provide automated quality and process data from instruments and vendor Certificate of Analysis (CofA), provide SPC in real-time at critical processing steps, enforce manufacturing workflows, and ensure compliance with all FDA regulations.
The Impact
Utilizing TrakSYS, Proteus was able to use real-time data to rapidly identify and investigate production roadblocks, and established process metrics that help create more accurate and complete cost models.
The team reduced the occurrence of paper on the shop floor, reduced errors associated with manual data entry, and expanded its TrakSYS deployment using only internal resources.
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