Rick Bump, President and Joel Ronning, Chairman
How can product quality and traceability be optimized to reap higher gains and meet FDA compliance in the pharmaceutical industry? ASI DATAMYTE has long established itself among global manufacturers as comprehensive quality management system provider to tackle pharmaceutical companies’ pervasive challenges around cost containment, regulatory compliance, traceability, and serialization in manufacturing processes. “As quality standards continue to evolve, we provide the agility and visibility drug manufacturers need to be successful by having access to real-time, shared data that is automated, reliable, and actionable,” says Rick Bump, President of ASI DATAMYTE.
The evolving economic and regulatory pressures continue to demand even more precision in drug manufacturing processes, imposing a high degree of responsibility on the organization. To comply with tightening new standards around serialization traceability, companies must implement robust data management systems that can generate, store, capture and transmit millions of serial numbers for numerous supply chains.
ASI DATAMYTE’s Quality Management System is comprised of a full suite of products around data collection, SPC (statistical process control), analysis & reporting, quality planning (APQP), hardware, and consulting services. The modular solution provides a framework for action-oriented, hierarchy-appropriate data collection, reporting and analytics to support not only the jobs of the line workers, but also the quality managers and executives.
DataMetrics™, the company’s industry-leading SPC solution, offers state‐of‐the-art setup and data collection for multitudes of production control variables, and pulls this data together through analytics and reporting to provide the framework for insightful decision-making.
As quality standards continue to evolve, we provide the agility and visibility drug manufacturers need to be successful
The solution helps companies define processes and employ alerts, notifications, and corrective actions accordingly before a production lot is released. Thus, it also empowers users to extract the data more easily to track and trace products in the case of an issue and immediately recall the specific affected production lot quickly and efficiently.
“What differentiates us from the competition is our 40+ years of expertise in the quality management industry serving top global manufacturers. Our team of seasoned experts invests time with our clients to understand how they will measure the success of an array of quality programs. With our modular suite of products we can effectively tailor solutions to meet their requirements,” explains Joel Ronning, Chairman of ASI DATAMYTE.
In a recent success story, a contract manufacturer of pharmaceutical products was looking to improve control of batch traceability, utilizing data collection and measurement control process to monitor net weight. Its main objectives were to meet compliance with fill regulations and to contain costs in one of its manufacturing processes. Partnering with the client, ASI DATAMYTE applied its data collection software that gathered data points specifically from the client’s checkweigher system.
The quality solution resulted in improved control, data visibility, and traceability of batches in production. With high integrity data collection, reporting, and ERP integration on a particular production line, the client was able to more accurately dose liquid drug in the containers and reduce fill by an average of 2.3 percent and increase production by 720,000 units, and comply with FDA standards.
ASI DATAMYTE is passionate about augmenting decision making and risk mitigation in manufacturing by developing new IoT (Internet of Things) technologies that build upon a complete, closed loop suite of quality management functionality that integrates planning, universal data collection, analysis, and reporting. To materialize its vision, the firm continues to proactively develop new technologies and cutting-edge innovations in its software and hardware product lines.