System access permission management

Electronic document management systems have the ability to distribute documents based on permissions or access control lists (ACLs). Document consumers can be notified automatically of a document s availability in the system. Once a file s status is updated to final or approved, a message can be automatically sent to members of a distribution list alerting them that it has been published. Access to the document can be further streamlined by attaching to the email a pointer to the file in the EDMS. 

There is a caveat to the application of Part 11. As noted, it is a permissive rule. Industry has the option of compliance. However, if a company currently uses any electronic systems to create, sign, modify, store, access, or retrieve records, it is presumed by the law that they have elected to follow the regulations and comply with the standards. Consequently, the company is subject to FDA enforcement of the rule under the food and drug regulations. If a company elects not to comply with the regulation, it must revert to all paper systems. No electronic systems are grandfathered under the Final Rule. Continued reliance on current electronic systems for any one of the electronic records management activities requires compliance with the requirements of Part 11 for security and controls.f (Preamble Comment XVI.C.l, p. 13463.)... 

RAM (random access memory) RDBMS (rotational database management system) read-only memory (ROM) read/write permission real time (noun) real-time (unit modifier)... 

Once the database-management-system is operative, the data access is secured by a permission and access rorrting scheme that allows selective data access according to job. Once access control and authorization is passed, all relevant data (upstream/downstream) are available. 

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