When dealing with Part 11 it’s important to understand what an electronic signature actually means.
The definition of electronic signatures or e-sigs can be found in 21 CFR Part 11.3(7).
Electronic Signature
An electronic signature or e-sig means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
Handwritten Signatures
We also need to understand what a handwritten signature means in the context of Part 11.
The definition of handwritten signatures can be found in 21 CFR Part 11.3(8).
Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.
The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
Electronic Batch Records
Eric works in a Pharmaceutical company and he is responsible for the filling process of the batch been manufactured.
Each time Eric performs the filling process he has to populate a batch record with the appropriate details
After each step Eric must also fill in his signature and date to verify that he actually performed each task.
Eric is manually handwriting these details and they are legally binding to Eric.
21 CFR Part 11.3(8)
This is when 21 CFR Part 11.3(8) applies.
Fast forward 12 months and Eric’s company has implemented a brand new Manufacturing Execution System (MES) where all details around the batch manufacturing process are recorded electronically.
21 CFR Part 11.3(7)
Now when Eric performs the filling process he now populates everything electronically and signs with his username and password combination to verify that he has performed those tasks.
This is when 21 CFR Part 11.3 (7) applies.