21 CFR Part 11
Companies Using Electronic Record Keeping Systems must Comply with 21 CFR Part 11
There are many challenges for companies who compete in rigorous FDA regulated environments. These companies that use electronic record keeping systems in place of paper systems must comply with FDA's 21 CFR Part 11 regulation. MasterControl has over a decade of experience leading the content management industry with electronic-based systems that address the real challenges of compliance with 21 CFR Part 11.
White Paper Downloads on 21 CFR Part 11
About MasterControl Inc.
For over a decade, MasterControl Inc. has been at the forefront of providing electronic quality management solutions. Hundreds of companies around the world use MasterControl's software solutions to attain and sustain compliance with FDA / EU regulations and ISO quality standards. MasterControl's integrated quality management system addresses the challenges of complying with the following:
- Annex 11 and other EU Directives
- 21 CFR Part 11, 210-211, 820
- ISO 9000
- ISO 13485
- ISO 14000
- Sarbanes-Oxley Act requirements
21 CFR Part 11 Compliance Software
MasterControl released the first document management software solution to address 21 CFR Part 11 and Annex 11 by providing all the security and electronic signature features necessary to ensure regulatory compliance year after year. MasterControl's approach to 21 CFR Part 11 compliance includes an integrated, easy to use system with applications that can be adapted to the unique needs of each company. These applications include 21 CFR Part 11 solutions for:
- Corrective and preventive action (CAPA)
- Change control
- Training control
- Document control
- Change control
- And more
The challenges of complying with 21 CFR Part 11 can be solved with MasterControl's time-tested automated quality system .
Learn More about 21 CFR Part 11 with Industry White Papers
MasterControl's Resource Center provides all the information regulated companies need to learn more about current industry issues, FDA regulations, 21 CFR Part 11, ISO quality standards, and software solutions. Companies can find the following educational and research materials:
- Product Data Sheets
- White Papers
- Q&As
- Tech Papers
- Case Studies
- Online Demonstrations
Questions? Contact MasterControl Today
Hundreds of companies around the world turn to MasterControl quality management solutions to address the challenges of complying with 21 CFR Part 11 and other regulations. Learn more about how MasterControl's solutions can help the unique needs of each company by contacting MasterControl online or calling toll free at 1-800-825-9117.
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