A stability result for a distributed batch trends toward the specification limit, or a pull point was missed.
Step-by-step process flow:
The agent
Watches every study for missed pulls and out-of-trend results, and alerts the owner early enough to assess the three-working-day Field Alert Report requirement.
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 trend, the batches in distribution and the clock. The agent never files a Field Alert Report.
Regulation
21 CFR 314.81(b)(1); ICH Q1A(R2).
What does the agent do for a stability trend that may require a Field Alert Report?
The agent watches every study for missed pulls and out-of-trend results, and alerts the owner early enough to assess the three-working-day Field Alert Report requirement.
What does the reviewer see?
The trend, the batches in distribution and the clock. The agent never files a Field Alert Report.
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 314.81(b)(1); ICH Q1A(R2).
Send an export for one batch or lot and see the workspace run on your own data.
