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FDA Compliance Made Simpler Any regulated organization needs to be responsible for all the electronic information that needs to be maintained and submitted to the Food and Drug Administration (FDA). The Code of Federal Regulations states that all records in the electronic form, can be modified, maintained, archived, retrieved or transmitted under any records requirements set in the FDA. The final regulation provided the criteria for acceptance by the FDA that electronic records were trust worthy reliable and equivalent to paper records and handwritten signatures executed on paper. It is of high importance to have a system in place that facilitates access and that can be controlled for the content of electronic records. These types of systems operate on the premise that the organization that creates and maintains the System information is also responsible for configuring, operating and maintaining the actual system. For any successful deployment, expert support is vital. As the FDA has various regulations, adopting a global lifecycle will make the regulations easy to adhere to. A global lifecycle product support helps to increase developer productivity and maximize the benefits and automates the monitoring of policies in addition to providing other benefits


Electronic Records-

 In providing a web-based and report based interface to obtain records for inspection, review and copying. The system also generates electronics form for the records through file based export of the data.  Allows users to a ready retrieval of data through the application interface.

 Limits each authorized user’s access of data and functionality.  Helps to maintain a rich audit trail for all the systems employed in the system.  Allows the organization to create an enforceable process that will help determine the sequence of steps and events.  Accepts data from validated process components installed within the system.  Enables users to perform the assigned tasks within the system.

Electronic Signatures

Electronic signatures executed to electronic records are linked to the respective electronic records to ensure that the signatures cannot be copied or transferred to falsify an electronic record.  Each electronic record has a unique system, thereby ensuring that there is no duplication of the same username.  Ensures a user authentication in the system.  Electronic signature can be executed by the genuine owner. Compliance can be made much simpler when there are adequate solutions. Information can be reviewed and reported to management to provide transparency to all of the mandatory regulations set by the FDA. An opposite application lifecycle management, is a huge advantage to any organization, as it provides an effective workflow based global platform to retrieve and transmit electronic data that is deemed necessary in the organization.

Also read about enterprise service bus (ESB) at Wikipedia.

FDA Compliance Made Simpler