Shared user accounts remain active on standalone balances or instruments.
Step-by-step process flow:
The agent
Reads the account lists of mapped systems and flags generic or shared accounts in use.
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
Regulation
21 CFR 11.10(d) and 11.300; EudraLex Volume 4, Annex 11, section 12.
What does the agent do for shared logins on standalone instruments?
The agent reads the account lists of mapped systems and flags generic or shared accounts in use.
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?
21 CFR 11.10(d) and 11.300; EudraLex Volume 4, Annex 11, section 12.
Send an export for one batch or lot and see the workspace run on your own data.
