21 CFR Part 11 Subpart C-Electronic Signatures

In the electronic transactions era, it is very important to understand the requirements as prescribed in this section of 21 CFR part 11 - Subpart C - Electronic signatures. The MHRA guideline titled, ‘GXP’ Data Integrity Guidance and Definitions dated March 2018 is also worth reading - Ramalinga Prasad Kuppa.

[@repallemuralidhar]

Nowadays this topic is very useful in pharmaceutical industry to maintain and secure the data as per the current guidelines formulated by regulatory bodies.

[@pharmaworldk1473]

Yes. There should be a detailed policy or SOP in the organization to capture all these requirements to handle electronic data recording through electronic signatures.