Part 11 Compliance during manual data entry

[Business Cat]

We are developing an electronic database solution in house. The way the system is setup is that it will take something like 10 data entries in each of its own cells and then the user can submit once they complete. The process flow is designed such that those 10 data points are taken right after another physically.

The question came up if the user will be allowed to delete any item as they are typing it in. My understanding is that once the record is submitted, we need to maintain audit trails to any changes to that record, but during the entry process, the user should be able to edit without the need for an audit trail prior to submitting that record. It's been a long time since I had to deal with data entry so I can't recall what we did in my previous roles. I went over the FDA guidance and various websites for help and didn't see anything stick out that would answer my question (it also could just be my Monday brain fog ).

Are we able to allow data edits prior to submission or do we need to prevent all editing after typing in prior to submitting the entries? Would anyone be able to point towards the section that lists it as well? Any help is appreciated in advance. Thank you

 

[Tidge]

If the 'approval' is at the time of submission, and that is when the audit trail begins... I see no issues with part 11 compliance. It isn't as if every webform used in an eQMS keeps track until submission.

If it was otherwise, we be allowed to have passwords like 1234%^&*abCD followed by 12 backspaces.