makes efficient document management software solutions


Document Control Software Systems / Quality Systems Software - MasterControl 21 CFR Part 11 document control, change control, CAPA quality management system software for FDA compliance, CAPA corrective actions, preventive actions, CAPA, Audits, Customer Complaints, Change Control, ISO 9000, ISO 14000, QS-9000 and computer systems validation


Corporate Overview

MasterControl Inc., based in Salt Lake City, has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage document and change control, training control, audits, corrective/preventive action (CAPA), customer complaints, Sarbanes Oxley compliance, and other quality and compliance processes under a single Web-based platform. It also offers comprehensive technical and customer support, including product training and validation services. Over 400 companies worldwide use MasterControl to comply with FDA and other regulatory requirements and ISO quality standards.

Our Beginnings

MasterControl was founded around the time American manufacturers were fully embracing the "quality management standards" movement as a response to competition from Japanese and other foreign manufacturers. Originally called Document Control Systems (DCS), the company's name stemmed from its niche software that catered to manufacturers conforming to ISO 9000 series (first published in 1987). The DCS software solution — called MasterControl™ — automated document control and other quality processes essential in attaining and maintaining ISO certification.

In 1997, the Food and Drug Administration issued 21 CFR Part 11, which allowed FDA-regulated companies to use electronic record-keeping systems to meet predicate rules, such as 21 CFR Parts 820, 210-211, and 606. With its experience automating document control processes for companies in the ISO environment, DCS saw Part 11 as an opportunity to expand to the FDA sector. DCS pioneered the development of software designed to help FDA-regulated companies automate their paper-based quality management systems and comply with Part 11's requirements pertaining to electronic records and signatures.

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