Part 11 Compliance

Part 11 compliance is essential for those FDA-regulated companies that wish to use electronic quality records and electronic signatures in place of their paper-based and ink-based counterparts.

21 CFR Part 11 was hailed as a landmark regulation when the FDA released it in 1997. The regulation finally made electronic records and signatures as valid as paper records and handwritten signatures. It is essential for regulated companies to atuomate their business and compliance processes in order to keep up with the pace of the burgeoning life science industries. MasterControl, Inc. provides document control quality management and product lifecycle managment solutions that are 100% Part 11 compliant.

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Part 11 Compliance with MasterControl

MasterControl helps regulated companies reach Part 11 compliance every step of the way. Part 11 compliance requires that various features be required in a quality management system and MasterControl can provide. Take a look at the following:

• Part 11 compliance dictates that regulated companies ensure the integrity of their electronic records and documentation. MasterControl ensures the integrity of documentation by allowing system administrators to create permissions for approved users and restricted access otherwise. The permissions can be assigned to personnel, to documentation vaults (storage areas) or to specified documents.


• Part 11 compliance dictates that the electronic system utilized by a regulated company be appropriately validated. MasterControl makes it twice as easy to perform validation by providing a validation toolkit, documentation, consultation and validation services.


• Part 11 compliance dictates that a minimization of a repudiation by a signer. MasterControl provides various levels of system security including multiple passwords that are encrypted for security.


• Part 11 compliance dictates that person utilizing the electronic system be properly trained to perform the tasks they have been assigned to perform. MasterControl makes it easy to streamline and automated training with the MasterControl Training™ solution which automates the delivery of training taks, the delivery of online exams, the grading of exams, follow-ups, escalations and a full-length training audit trail.


• Part 11 compliance dictates that document controls in the electronic system include document version controls, change control and time-based system modification capabilities. MasterControl provides all of these features via the Part-11 compliant MasterControl Documents™ solution.


• Part 11 compliance dictates that handwritten and electronic signatures be linked to the appropriate records. MasterControl can automate this process so all related documentation is linked and ready to be shown to an internal or external auditor if the need should arise.

For More Information

To learn more about reaching complete Part 11 compliance, please feel free to contact a MasterControl representative.