Glenn McCarty, CEOSuccess in the Life Sciences industry is defined by rapid product development processes that are responsive to changing market demands in adherence to Food and Drug Administration (FDA) regulations.
However, there are not many quality management software systems that can adapt to the changing market need, provide tools to shorten product development lifecycles, manage the supply chain, and maintain compliance with a wide range of regulatory requirements. EtQ, a Farmingdale, NY based company addresses these challenges with its FDA Compliance Management Software—which uses best in class integrated modules and enterprise applications, to help manage and measure quality and compliance processes, and execute organizational changes. “The development of EtQ software came out of a growing need in the market for software automation that adapts to compliance standards,” says Glenn McCarty, CEO EtQ.
The company has developed a “Flexible Workflow Engine” platform that is robust enough to handle all the workflows and business rules associated with Quality Assurance, but at the same time flexible enough to be changed as needed, without any programming skills. It allows the form layout, fields, sections, approvals, notifications and hundreds of other features of each compliance process to be configured with intelligent, condition-based decision capabilities so that the user does not have to “remember” them.
The company also offers a solution to close the gap between production and the quality systems—the EtQ Connection Profiles. Modules like Non conformance Management and Complaint Handling Software connect to ERP and CRM systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughout the event resolution process.
EtQ has extended compliance through its mobile platform, which is available within Reliance, a web-based, enterprise system for quality and compliance management.
Our goal is to make overall compliance operations and management systems better for businesses
The concept takes enterprise mobility to new heights by ensuring that compliance data is always close at hand, enabling users access to different applications while offline, and then synchronize all segments of completed tasks to the Reliance system.
“As organizations are increasing in complexity; compliance is becoming more difficult to manage and track. In order to remain competitive, they need to categorize and prioritize compliance events by risk,” explains McCarty. One of the company’s clients was challenged in discerning the most critical events among all the incoming data every day that affect quality and safety of the drug products. Identifying and acting upon the most critical events was indispensible for their practice. EtQ implemented a risk-based Quality Management System which allowed the client to put quantitative and systematic measures on high risk factors and address them first. This resulted in reduction of the number of adverse events handled by client.
Today, EtQ’s technological expertise has not only made them experts in Life Sciences industry, but also in verticals including Biotechnology, Consumer Goods, Energy, Transportation, Food and Beverage, and more. In addition to their leading Quality and Compliance Management Solutions, EtQ also provides a best-in-class Environmental, Health and Safety Management Solution, which helps organizations manage and track compliance related to EHS. Going forward, the company continues the tradition of “innovating every year” to come up with newer product versions that match customer needs. “We design our products based on market and customer feedback, and other different ways to bring out the innovation that makes sense for our customers and the market needs,” says McCarty.