CHICAGO, Aug. 11, 2021 /PRNewswire/ — Celegence, a global provider of regulatory affairs services and solutions for the life sciences industry, is pleased to announce the latest release of its state-of-the-art MDR compliance cloud solution, CAPTIS. The solution simplifies the process of writing PMS documentation for EU MDR compliance. One example of how it achieves an over 20% increase in productivity for medical writers is through its seamless integration with literature and adverse event databases to automate the creation of post market surveillance documentation such as Clinical Evaluation Reports and Post Market Safety Reports.
CAPTIS successfully decreases the turnaround time of the required documentation with features such as document lifecycle management, source document management and improved collaboration between medical writers, Subject Matter Experts, and clients.
“With the creation of CAPTIS, we are addressing the increasing resource burden that the EU Medical Device Regulation has created for the medical device industry. With each new release of the solution, we improve the productivity, compliance, and quality for our clients and for our own medical writing team,” says Sonia Veluchamy, Chief Executive Officer at Celegence.
CAPTIS is a groundbreaking solution for the RA/QA departments in the medical device industry looking to increase compliance and reduce the burden on their resources. An overview of the innovative platform is available here: Introducing CAPTIS, however a thorough demo of the application can be arranged with the Celegence team.
CAPTIS is already being utilized by Celegence’s internal medical writers to achieve greater operational efficiency. If you would like to learn more about how CAPTIS can help you and your organization with regulatory compliance, please contact a Celegence representative today at [email protected].
Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs. Celegence supports life sciences customers in the areas of EU MDR compliance, regulatory intelligence, RIMS data management, publishing, regulatory labelling including UDI consulting, medical writing and compliance toward new regulations for different product portfolios. Celegence’s depth of experience and extensive delivery capability allows regulatory affairs teams to operate more efficiently, reduce cost, and improve compliance. For more information, visit www.celegence.com or follow Celegence on LinkedIn.
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