FDA Compliance
With over a decade of industry specific experience, MasterControl provides time-tested solutions to real FDA compliance challenges.
FDA compliance regulations, such as 21 CFR Parts 11, 210-211, 820, and 606, and similar EU quality standards guide the present state and future growth of the natural science industry. However, maintaining a continuous state of FDA compliance is a challenge. MasterControl Inc. has been at the forefront of providing quality management software since 1993. With over a decade of industry specific experience, MasterControl provides time-tested solutions to real FDA compliance challenges.
About MasterControl Inc.
For over a decade, MasterControl Inc. has led the document management industry. With time-tested document and process control automation software and impeccable customer service, MasterControl helps companies attain and sustain compliance year after year. Hundreds of companies around the world use MasterControl's integrated FDA compliance software solution to address the unique challenges of FDA compliance.
White Paper Downloads - FDA Requirements
Attain and Sustain FDA Compliance
It is possible to attain and sustain FDA compliance year after year. With MasterControl's integrated document management system, regulated companies can meet and exceed FDA compliance requirements. The quality management system includes the following applications that can be configured to meet the unique needs of each company:
- MasterControl Documents™
- MasterControl CAPA™
- MasterControl Training™
- MasterControl Forms™
- MasterControl Change Control™
- MasterControl Audit™
- MasterControl Customer Complaints™
- MasterControl Nonconformance™
- MasterControl SOX™
- MasterControl Submissions Gateway™
Making “Continuous Validation” Possible
FDA compliance regulation, specifically 21 CFR Part 11, requires the continuous validation of electronic record keeping systems to ensure the accuracy, reliability, and consistent intended performance of the system. MasterControl validation services offer companies continuous validation with the following time-tested methods:
- Full-Cycle Validation
- Validation Toolkit
- Continuous Development
For More Information
Achieving FDA compliance can seem like a daunting task. Choosing a quality management software solution that fits the unique needs of each regulated company can be just as challenging. MasterControl's Resource Center provides inquiring customers with all the educational and research materials they need to learn more about the industry, FDA and EU regulations, and their integrated software solutions. The Resource Center offers the following:
- Product Data Sheets
- White Papers
- Q&As
- Tech Papers
- Case Studies
- Online Demonstrations
Contact MasterControl online or call toll free at 1-800-825-9117 to learn how their quality management system goes beyond software to provide real solutions to real challenges.
Related Items:
- FDA
- Quality Control System
- Compliance Contract Software
- Standard Operating Procedure
- Complaint Management Software
- QMS
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