FDA 21 CFR Part 11

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.


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Educational Materials

Get insider information about the most relevant issues in 21 CFR Part 11 today, and how to navigate and overcome the complexities of FDA Regulations.

Product Data Sheets
White Papers
  • Prepare for an inspection by delving into FDA's 21 CFR Part 11 guidance from 2003 and learn how to maintain documentation that stands up to scrutiny not only during inspection, but over time.
  • This white paper delineates FDA's expectations and current thinking on 21 CFR Part 11 according to its 2003 Guidance for Industry. Also, learn how MasterControl's integrated software provides functionality that fully satisfies Part 11 requirements.
  • Gain an overview of computer systems validation and FDA's current expectations, and learn how the GAMP methodology and validation-ready software can greatly simplify Part 11-compliance.
  • Gain an overview of computer systems validation and FDA's current expectations, and learn how the GAMP methodology and validation-ready software can greatly simplify Part 11-compliance.
  • Effective complaint handling is not just a good business practice, but a critical compliance requirement in FDA and ISO environments. Learn the strategies and solutions for managing complaints and turn complaints-related challenges into opportunities for improvement.

Product Information

Discover how MasterControl Quality Management Software can manage your FDA 21 CFR Part 11 process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • Discover how MasterControl Customer Complaints™ addresses the three key complaints-handling challenges of different sources, disconnected processes and an inefficient complaint process by automating complaint handling and integrating it with your quality system.



FDA 21 CFR Part 11 Compliance Solutions


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). In 1998, MasterControl became the first software provider to release a software solution that addressed FDA 21 CFR Part 11 regulations. 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's FDA 21 CFR Part 11 Compliant Quality System


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:

  • Part 11 Section 11.10 requires an assurance of the authenticity of electronic records. MasterControl allows system administrators to delineate user permissions for every document vault in the system. MasterControl also creates an audit trail of any captured document.
  • Part 11 Section 11.10 also requires that the possibility that a signer would repudiate an approval be minimized. MasterControl requires users to enter two passwords to approve any type of document collaboration. The first password is the login password and the second password is an approval password.
  • Part 11 Section 11.10a requires the validation of the electronic system. MasterControl has developed tools, solution and services that can reduce the effort of software validation for FDA 21 CFR Part 11 by 50%.
  • Part 11 Section 11.10i requires that all those who have been approved to use the electronic system are trained to perform assigned duties. MasterControl provides training automation that is automatically triggered when an essential quality document is revised to ensure sustained FDA 21 CFR Part 11 requirements. MasterControl training also automates the follow-ups and escalations of past-due training and creates an audit trail of all training data.
  • Part 11 Section 11.10k requires document controls that provide revision controls, change controls and time-based system modifications. MasterControl provides all of these document control features.
  • Part 11 Section 11.50a requires signed electronic records with the following data: name, date/time of signing, and meaning of signature. MasterControl provides fields for all required information to ensure FDA 21 CFR Part 11 compliance and for additional information if additional fields are desired by the user.
  • Part 11 Section 11.70 requires the linking of electronic (and handwritten) signatures to their corresponding electronic records. MasterControl automatically links every signature to a specified record.

How Does MasterControl Software Ensures the Structure to Go Beyond Compliance with FDA 21 CFR Part 11?

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.

FDA 21 CFR Part 11 Compliance with the MasterControl Quality Suite

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:

  • MasterControl Documents
  • MasterControl CAPA
  • MasterControl Training
  • MasterControl Process
  • MasterControl Change Control
  • MasterControl Audit
  • MasterControl Customer Complaints
  • MasterControl Nonconformance
  • MasterControl Submissions Gateway

For More Information on Document Control Software Systems


For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.