Talking about FDA’s code of federal regulations

You can’t find anything which is not supported by rules. Rules are everywhere. And if you are one of those who strictly follow rules, you should also be known about those rules that are made & regulated by FDA in U.S., those that caters to the fields of medical services, psychological research etc. So, it is somewhat paramount for you to know about such rules written by federal agencies. And yes, these agencies have now crept into the utility of information made by us. Now that there is smart phone revolution which has positively affected productivity & efficiency, there are digital forms of everything we use. Records are managed digitally rather than on paper nowadays. So, some kind of regulations is needed to deal with electronic mode of records management & for that, there is 21 Code of Federal Regulations. Let’s just go through some of the basic aspects of this code of regulations.

In order to deal with electronic records & electronic signatures that are widely taken in use, Food & Drug Administration of U.S. has set forth some guidelines which are included in this FDA’s code of federal regulations. There are several parts of CFR where similar other regulated areas are given & all pharmaceuticals & medical device industry regulations are enlisted in 21 CFR. More specifically, the electronic records & signature’s aspect is given in its part 11.

And it’s not just a part, it’s a law which keeps a check on the accuracy, authenticity, reliability & control over electronic records &signatures employed for use by business organizations. It allows the conversion of any paper record to its electronic form 7 vice versa. However, there had once existed controversy over Part 11 of 21 Code of Federal Regulations over subsequent years after its formation.

Basically, it was made & designed to offer organizations & companies based on life sciences with greater flexibility over implementation of controls. And it is with revision of rules & guidelines set that confusions about its advantages are getting cleared.

It was needed as one of the FDA’s code of federal regulations for ease of business processing in sectors of Life science & other FDA regulated companies by structuring standard guidelines for use of electronic records & signatures.