A handwritten correction on an executed record page has no initials, no date or no reason.
Step-by-step process flow:
Today
Found if the reviewer notices it on the page.
The agent
Reads scanned pages, detects corrections, and checks for initials, date and reason. Low-confidence reads go to a person.
Next
A follow-up to the line supervisor for the record owner.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
REVIEW AND REGULATION
The reviewer sees
The page image, the marked correction, the missing element and the confidence score.
Regulation
EudraLex Volume 4, Part I, Chapter 4 (documentation), which requires alterations to be signed and dated, with the reason recorded where appropriate; 21 CFR Part 211.
What does the agent do for a correction with no initials, date or reason?
The agent reads scanned pages, detects corrections, and checks for initials, date and reason. Low-confidence reads go to a person.
What does the reviewer see?
The page image, the marked correction, the missing element and the confidence score.
What happens after the reviewer confirms?
A follow-up to the line supervisor for the record owner.
Does the agent make the decision?
No. The agent prepares the finding and a named person decides. The agent never releases, certifies or dispositions a batch, never closes a deviation, investigation or CAPA, and never files anything with an authority.
Which regulations apply?
EudraLex Volume 4, Part I, Chapter 4 (documentation), which requires alterations to be signed and dated, with the reason recorded where appropriate; 21 CFR Part 211.
Send an export for one batch or lot and see the workspace run on your own data.
