Learn from industry practitioners and experts why implementing a FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl Inc. introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform. MasterControl GxP process management software solutions go beyond FDA 21 CFR Part 11 requirements and regulations to help companies also sustain current industry "best practices (CGxP). Since then, MasterControl has continued to go beyond requirements for implementing a GxP process management software solution for easier compliance, faster validation, and better CGxP process management.
MasterControl has developed state-of-the-art document control and quality management solutions that are 100% compliant with FDA 21 CFR Part 11 regulations. MasterControl's solution features provide the following benefits:
In 1998, MasterControl Inc. introduced the first document control software especially designed to help the life sciences industry comply with FDA 21 CFR Part 11. Since then, hundreds of companies worldwide have been using the MasterControl quality management suite - an integrated, configurable, off-the-shelf, and easy-to-use software solution - to comply with various FDA regulations.
The MasterControl suite is easy to use, easy to validate, and easy to maintain. With a continuum of integrated applications and the support of risk-based software validation products and services, life science companies around the world trust MasterControl suite. The MasterControl suite includes the following applications that can be configured to meet FDA 21 CFR Part 11 regulations and the unique needs of each company in their various industry sectors:
For additional details about 21 CFR Part 11, please feel free to contact a MasterControl representative.