"...there are many ways to address design controls in the context of 483s. We hope readers of this eBook come away with that understanding and a better sense of how to approach design controls from both a proactive and corrective manner."
LEXINGTON, Mass. (PRWEB) June 11, 2019
FDA Form 483s are notifications delivered to life science organizations after regulatory inspections detailing conditions observed by investigators to be in violation of the Federal Food, Drug, and Cosmetic Act. While these observations are not final rulings by FDA, they are intended to ensure life science products remain safe and effective for consumers.
Cognition’s new eBook reviews the basics of 483s and the important reasons for managing design controls to avoid citation. By detailing the adverse impacts that a 483 related to design controls can have on an organization, the eBook intends to dig into ways of better managing design controls compliance.
“Looking at recent data, we were intrigued by just how many 483 citations there were regarding Design Controls regulations,” says David Cronin, CEO of Cognition Corporation. “We wanted to explore just what that means, and why robust design controls are so important for life science product development.”
The new eBook takes the recent 483 data and extracts information related to the most commonly cited design controls in recent years. Looking at this data and exploring what it means, the eBook offers insight and suggestions to life science organizations regarding ways to bolster their compliance efforts.
“Whether it’s through more dynamic and robust risk management, better-aligning processes and procedures to compliance objectives, or otherwise,” says Mr. Cronin, “there are many ways to address design controls in the context of 483s. We hope readers of this eBook come away with that understanding and a better sense of how to approach design controls from both a proactive and corrective manner.”
The white paper is available for download here.
Cognition Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition offers the Cognition Cockpit™ Platform, along with engineering and validation support, and industry expertise. Thousands of users worldwide use Cognition solutions to manage their product development process and meet regulatory, performance, and-time to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.