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21 CFR Part 11 Compliance Checklist

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Data Sheet 1 Data Sheet 21 CFR Part 11 Compliance Checklist If your company is planning to convert to an automated system for managing documents and business processes, make sure that the new system meets the needs outlined in the following 21 CFR Part 11 compliance checklist: □ Authentic Electronic Records: 21 CFR Part 11 requires an assurance of the authenticity of electronic records. To maintain compliance, system administrators need to have a system that includes functionality 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. □ Multiple Password Authentication: 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 approvals. □ Computer System Validation: The FDA requires that any electronic system used to manage compliance-oriented documents and processes 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. □ Integrated Personnel Training: 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 automatically trigger new training courses when an essential quality document is revised in order to ensure sustained organizational compliance with 21 CFR Part 11. A system with a proven training component should also be able to automate the follow-ups and escalations of past-due training tasks, create audit trails for all training information, and maintain employee training records. □ Effective Change Control Management: 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.

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