Features of ALM Solution to ably manage Compliance to FDA 21 CFR Part 11
It’s a well known fact that part 11 of the 21st Title of the Code of Federal Regulations applies “to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in the Food and Drug Administration (FDA) regulations.” Published in 1997, the final regulation provider the criterion for acceptance by the FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic records as “trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper” (Chapter 1, Part 11).
So how does one adhere to the norms of the FDA and also ensure that an enterprise can enjoy the control and maintenance of these compliance measures? The answer is pretty simple to effectively manage compliance with FDA 21 CFR Part 11, requires an enterprise to adopt an application lifecycle management (ALM) solution that allots them complete control of all kinds of configuration, operation and maintenance. A solution that gives the client(in this case the enterprise the control to configure and maintain different aspects of their systems, thereby ensuring that the overall accountability resides with the client themselves, such a solution would prove immensely helpful for the client who wants to manage compliance according to FDA.
An ALM solution which offers complete compliance control for FDA 21CFR Part 11 allows the client and their personnel to create, modify, maintain or transmit electronic records only when they follow the appropriate procedures and controls that will ensure complete authenticity, integrity and confidentiality of electronic records. Additionally such measures ensure that the signer from the client’s side cannot simply repudiate the signed record as not genuine.
Features of such an ALM support solution would necessarily include:
- A validation process of the systems to guarantee accuracy, dependability, performance consistency and the ability to discern invalid or altered records
- The ability to create precise and complete copies of records in both readable and electronic form that can be easily inspected, reviewed and copied by the agency
- Complete protection of records to ensure their accuracy and ready retrieval all through the records retention phase
- A system which limits access to authorized individuals only
- Using secure, computer generated, time-stamped audit trails to independently record the date and time of operator entries and actions that creates, modifies or deletes electronic records
- The ability to not obscure previously recorded information, which means audit trail documentation, shall be retained for a period so long as it is required for electronic records. It will therefore be available for agency review and copying.
- Using an operational system check to implement permitted sequencing of appropriate steps and events
These were a few features that an optimized ALM solution would necessarily be equipped with in order to effectively manage Compliance to FDA 21 CFR Part 11(Electronic Records and Electronic Signatures)
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