ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), announced a technology partnership with T-Systems North America in its effort to help Life Science sector’s transformation to Industrial Internet of Things (IIoT) Technology, which is becoming extremely critical in pharmaceutical and biotech manufacturing where sub-optimal environmental conditions have often lead to noncompliance.
Pharma IoT aims to maximize transparency in drug manufacturing, storage, and logistics by allowing multiple sensors to monitor environmental indicators, including temperature, humidity, radiation, and light, in real-time. For this transformation, digitization of manufacturing facilities such as cleanroom environments is an initial step to automate data collection through monitoring devices. Currently, cleanroom operators need to log data into the ValGenesis VLMS system. With an IoT interface, users can expect smooth and uninterrupted automated collection and monitoring of data in real-time with alerts for out of specification limits through ValGenesis VLMS. The IoT-enabled ValGenesis VLMS system continues to provide, more efficiently, assurance of data integrity, facilitates high manufacturing process capability and efficiency and tracks compliance to established procedures. These are just a few examples of features that ValGenesis plans to enhance its collaboration with T-Systems. The use of IoT in the ValGenesis system and applications for supply chain and other validated manufacturing processes are in development.
“ValGenesis VLMS has long been a trusted name for paperless validation, and ValGenesis is committed to continual improvement. As part of this commitment, this partnership with T-Systems allows us to expand and enhance our digital validation solutions. At ValGenesis, we continually seek to enhance quality assurance, data integrity, and regulatory compliance while improving the overall efficiency of corporate validation programs,” says Dr. Siva Samy, CEO & Chief Product Strategist at ValGenesis, Inc.
“Innovation and continual improvement are necessary to be competitive, and in the highly regulated Life Science industry, it is essential to prevent adverse regulatory actions as today all of us value our experiences more and more. With increasing emphasis on real-world evidence by regulators and patients, the weight they place on the assurance of data integrity and process and product quality is rapidly increasing. Today, media headlines and social media posts and tweets remind us, often several times each day, that we are in an experience economy. The need to reduce errors and costs while increasing attention and productivity puts tremendous pressure on companies. Technological solutions that ease this tension are essential for remaining in business. The commitment to customer satisfaction, continual improvement, and innovation visible at ValGenesis is indeed impressive,” says Dr. Ajaz S. Hussain, Member of the Board of Directors ValGenesis, Inc., and former Deputy Director at CDER – US FDA.
“T-Systems sees ‘value in compliance’ through the use of IoT devices that improves adherence to FDA regulations and technology that is helping the industry to lower costs and improve productivity. We look forward to other Digital Transformation initiatives through this partnership,” said Jim Sabogal, Head of Healthcare and Life Sciences at T-Systems.
“End-to-End solutions in a fragmented Internet of Things universe is what T-Systems brings to the industry to not only innovate but add value to our customers. Our ability to provide accurate and repeatable ‘condition monitoring’ (temperature, humidity, and pressure) with these devices combined with our partner solution brings win-win for our mutual end-customers,” says Alex Martinez, Head of Emerging Technologies for T-Systems.
Working together, T-Systems and ValGenesis are improving operator efficiency and providing actionable data on-time. Real-time notification of what’s happening in different parts of a business is an essential step for improving the accuracy and efficiency of drug development processes. Attention to the efficient implementation of ValGenesis solutions is our responsibility. For example, a recent application proof of concept for a monitored cleanroom took just two weeks, and full implementation is planned by Fall 2019.