FDA 21 CFR Part 11 Compliance

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.