Document Management

FDA Regulated Companies

In order for companies in life sciences industries like pharmaceutical, medical device, biotechnology and blood establishments to stay on top in an Internet-paced environment, they must work smarter and more efficiently. The inability to effectively manage complex documentation to meet regulatory compliance and new product approval - with increasing regulatory demands - are major factors in slowing the time it takes to bring a product to market. These delays can cost companies millions in potential lost revenue.

The 21 CFR Part 11 final ruling that was released in 1997 outlines FDA guidelines for accepting electronic documentation and electronic signatures. This ruling opened the door for the life sciences to incorporate electronic document control and change management technology into their current business processes. Soon after the release of regulation 21 CFR Part 11, Document Control Systems, Inc. (DCS) developed a new version of their existing MASTERControl software and named it MASTERControl Documents FDA .

MASTERControl Documents FDA was the first document control and change management software to enable pharmaceutical, biotechnology, medical device and other FDA-regulated industries to meet FDA GxP requirements and to comply with 21 CFR Part 11. It is designed as configurable, off-the-shelf software for rapid implementation that can be installed, configured and validated quickly.

The MASTERControl³ architecture is the power behind each MASTERControl application and provides all the essential building blocks to construct any regulatory or quality management system to boost operational efficiency, improve product quality and drive compliance with regulatory and quality standards.
The MASTERControl suite of products are specifically designed to be Compliant, Connected and Complete (C³).