12 Sep 2012
DANVILLE, Calif.–(BUSINESS WIRE)–CSOFT International Ltd., a leading provider of multilingual globalization services and language technology solutions announced today the launch of an online webinar series aimed at explaining the importance of product terminology management and its role in meeting international regulatory requirements for life sciences companies. The webinars are available free of charge for compliance managers, quality control professionals, and documentation managers at pharmaceutical, medical devices, and biotechnology companies.
Regulatory compliance is designed to ensure the safety of millions of customers around the world, and is a mandatory requirement for the life sciences industry. As electronic documents replace paper records in the fields of R&D, manufacturing, content development, and other functions, companies need to understand, manage, and control the flow of digital information. In fact, the FDA requires that these systems maintain the digital equivalent of a paper trail. Regulation 21 CFR Part 11 sets strict criteria for electronic signatures and documents. Non-compliance may lead to fines, delays and even halting operations into a particular locale. Products could be quarantined indefinitely and lofty fines levied against non-compliant companies.
In the case of terminology management, a paper trail means the detailed tracking record that shows the creation, review, alteration, approval, and version control of each important product terminology. The ability to show who made particular alterations to each term at all times is vital to a digital paper trail that can serve as evidence to auditors in a compliance audit.
“As important as terminology management is, many life sciences companies either do not do it at all, or lack a mature process to manage the requirement systematically,” commented Carl Yao, VP of Global Strategy at CSOFT International. “Having a set of well-developed terminology clearly defining each important product component and application is critical for companies in the life sciences industry. Incorrect terminology not only leads to confusion and poor translations, it can have a direct impact on patients’ safety and may cause a product to fail in international regulatory compliance requirements.”
Studies show that a significant percentage of all content and translation quality issues are terminology related. These terminology webinars are designed to help life sciences companies understand the importance of terminology management in terms of improved product quality and international regulatory compliance by keeping detailed records of the entire terminology development process, from initial creation, to validation, and sign-off. The webinars also aim to help companies establish best practices so they are able to streamline how terminologies are created, reviewed, translated, and approved. Terminology experts will demonstrate how to get started with managing product terminology that is tailored to meeting global compliance requirements.
To sign up for the terminology management webinar series for the life sciences, go here.
About CSOFT International
CSOFT International Ltd. is a world leader in localization and globalization consulting services, providing turnkey solutions for companies facing the challenges of engaging customers and markets across linguistic and cultural barriers. Recognized as one of the Top Innovative Companies in 2011 by IDC we have an award-winning international team. In 2012, the company’s CEO was named one of Fortune Magazine’s 10 Most Powerful Women Entrepreneurs and a Tech Disruptor by CNN Money.