The contamination control strategy references risk assessments that have since been revised or moved.
Step-by-step process flow:
The agent
Reads each reference in the strategy and checks its current revision in document control.
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
EudraLex Volume 4, Annex 1 (2022), contamination control strategy.
What does the agent do for a contamination control strategy whose sources have moved?
The agent reads each reference in the strategy and checks its current revision in document control.
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, Annex 1 (2022), contamination control strategy.
Send an export for one batch or lot and see the workspace run on your own data.
