A pack order was packed using an artwork revision that had been superseded under a change control before the packing date.
compliance agent · packaging review
"Packed against artwork revision C. Revision D became effective in May under change control CC-24-112."
REVISION USED
C (superseded)
STATUS
Awaiting reviewer
Held for reviewer · multiple sources + reasoning
Step-by-step process flow:
Today
Artwork revisions live in document control, packing records on the line. Nobody lines up the dates unless a complaint arrives.
The agent
Reads the pack order and packing date from the ERP, the revision history from document control, the change control from the quality system and the line clearance from the executed record.
Next
A follow-up to the packaging owner, tracked until disposition.
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 revision used, the revision in effect, the change control, and the dates, with reasoning. (Full example on the Pharmaceutical page.)
Regulation
EudraLex Volume 4, Part I, Chapter 5 (packaging operations); Directive 2001/83/EC, Articles 56a and 61; Commission Delegated Regulation (EU) 2016/161.
What does the agent do for packing against a superseded artwork revision?
The agent reads the pack order and packing date from the ERP, the revision history from document control, the change control from the quality system and the line clearance from the executed record.
What does the reviewer see?
The revision used, the revision in effect, the change control, and the dates, with reasoning.
What happens after the reviewer confirms?
A follow-up to the packaging owner, tracked until disposition.
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 5 (packaging operations); Directive 2001/83/EC, Articles 56a and 61; Commission Delegated Regulation (EU) 2016/161.
Send an export for one batch or lot and see the workspace run on your own data.
