Novatek Communications Introduces Process Protection to Help Manufacturers Meet Compliance Requirements
Friday, April 25, 2014
Novatek Communications, Inc. introduced today Process Protection, a quality systems documentation service designed to help regulated companies meet compliance requirements faster.
Process Protection services include an assessment of quality system documentation or procedures currently in place, gap analysis with regulatory standards, and technical writing services to document and refine standard operating procedures and create company-specific work instructions. This service can help medical device and other industry manufacturers faced with:
- FDA consent decree or citation
- ISO certification process
- Centralization or standardization of processes
“Regulatory challenges cost the medical device industry billions every year due to lost revenue, market share, reputation and stock prices,” Novatek President Amy Castronova stated. “Novatek helps to manage the risk by ensuring that operating procedures are documented in a way that meets compliance standards, but also are used in day-to-day operations.”
The new Process Protection offering includes a jumpstart approach and leverages Novatek’s 25 years of experience in regulated environments to speed time to compliance. To learn more, visit http://www.novatekcom.com/services/process-protection/.
About Novatek Communications, Inc.
Since 1989, Novatek Communications has helped companies in regulated and deadline-driven environments launch new products and capture key processes. Novatek provides technical writing and training services to medical device companies and other manufacturers launching new products, setting up a QMS, or facing regulatory and compliance challenges. Novatek’s custom documentation and training materials result in Active Knowledge—knowledge that improves usability and customer satisfaction. Delivering the right information to each audience and in the most effective format is what distinguishes Novatek’s modern documentation from standard technical writing; learning from training. Learn more at http://www.Novatekcom.com.