FDA 21 CFR Part 11 Compliance and Checklist

21 CFR Part 11 requires an assurance of the authenticity of electronic records. To maintain compliance, system administrators need to have a system that offers the ability to delineate user permissions for every document vault in the system. The system must also be able to generate an audit trail for any captured document.

The potential for a signer to repudiate an approval must be minimized. An automated system meeting the requirements of the 21 CFR Part 11 checklist should require users to enter two passwords to approve any type of document collaboration, one password for login and another for approval.

The FDA requires that the electronic system must be validated. Implementation of an electronic system with a proven track record of performance and validation can drastically reduce the time and money a company devotes to its overall validation efforts. Depending on the company's internal corporate policies and risk evaluations, validation can be as simple or as thorough as the electronic system will allow.

According to 21 CFR Part 11, all users who have been approved to use the electronic system must be sufficiently trained to perform their assigned duties. A system that incorporates automated training capabilities can provide automatic triggers when an essential quality document is revised in order to ensure sustained 21 CFR Part 11 compliance. A system with a proven training component should also be able to automate the follow-ups and escalations of past-due training tasks as well as create audit trails for all training data.

Document controls must provide revision controls, change controls, and time-based system modifications. In these regards, an organization's internal business processes and specific corporate protocols must be evaluated in order to determine what is needed to formulate an individualized 21 CFR Part 11 compliance checklist.

21 CFR Part 11 compliance requirements also mandate that signed electronic records include the following data: name, date and time of signing, and meaning of signature. An effective electronic system should provide fields for all such required information to ensure 21 CFR Part 11 compliance as well as for supplementary information (if such fields are desired for use).

Electronic (and handwritten) signatures must be able to be linked to their corresponding electronic records. An established electronic system should easily be able to link every signature with a specified record.