Everything You Should Know About 21 CFR Part 11

Posted by rohny01 on January 12th, 2020

It would not be wrong to say that with time the advancement of technology has been improving so rapidly. There have been so many life science manufacturers as well as distributors who have been considering choosing some digital manual and electronic transactions as the primary medium. The method of using electronic signatures and records will enable you to simplify the whole process of replacing paper documentation.

Right in this blog post, we will be having a quick overview discussing what 21 CFR Part 11 is all about and in what way Enterprise Quality Management System (EQMS) will be helpful as in modernizing compliance.  

Introduction about 21 CFR Part 11

21 CFR Part 11 is known as the form of the section, which is part of the Code of Federal Regulations (CFR). This section will be setting the guidelines of the FDA in favor of using the electronic signatures and performing a record session for the regulated life science-based companies. Part 11 compliant system hence establish complete criteria in which all your signatures and electronic records are deemed into a reliable mannerism and are often equal to the course of paper documentation.

Part 11 Offers Secure Foundation for Managing Records 

Part 11 is reinforcing a stable and reliable foundation for managing all your record distribution and storage access. FDA has regulated all those organizations who are involved in keeping the records should be complying with their regulation. All the global regulations have been closely aligned with the 21 CFR Part 11. All those companies who have been implementing the compliant system of Part 11 are taking an instant benefit of taking into account excellent data integrity practicing in a complete global environment.

Part 11 Helps In Managing Password 

Having an excellent and secure password management will be adding upon another set of layer for the proper security of your business documents. You need to undergo certain password practices in which you should be changing your password regularly and create some strong passwords all the time. This can include a complete mix of numeric values, lower letter, or some special characters.

If the system of your business is being regulated by some FDA agency, then definitely they will be considering carrying out a complete checking on your documentation system. This will let them know about all the events that happened throughout your business. These events can be about when the records were created or specific changes in the record.

Hence data security is considered to be one of the most essential elements in the 21 CFR Part 11 compliance. All those organizations who are working with some sensitive documents or data should make sure a complete access of security for their data. It would be best if you were having full controlling access on your documents. In this regard, you can make the use of certain data security management software which can definitely make the whole security process easy to perform and effortless for you.