COMPLIANCE AGENTS
Each agent replaces a specific piece of work a person is doing today. Every agent shows its reasoning, starts at Level 1, and cannot promote itself.
AGENT LIBRARY
Cockpit
Reads every other agent and ranks what matters
REPLACES
Status meetings to learn where things stand
PRODUCES
Readiness verdict across open exceptions
NEVER
Never changes a record, files anything or contacts anyone
Execution
Finds the deviation nobody raised, and the pattern across the ones that were
REPLACES
Searching the quality system for events not reflected in records
PRODUCES
Deviation-to-batch citation check
NEVER
Never closes an investigation or assigns a root cause without a person signing it
Execution
Flags CAPAs likely to fail their effectiveness check before they are closed
REPLACES
Rereading closed CAPAs to spot weak ones
PRODUCES
Revised CAPA with the effectiveness criterion changed
NEVER
Never closes a CAPA or changes an effectiveness criterion without approval
Execution
Reviews the batch record so the person reviews the exceptions
REPLACES
Page-by-page first pass of executed records
PRODUCES
Batch exception summary with clean pages marked
NEVER
Never releases a batch. Release stays with the Qualified Person or the person named in the procedure
Execution
Maps each finding to every authority that cites it
REPLACES
Manually tracking which documents apply per market
PRODUCES
Market applicability sheet per batch
NEVER
Never files, submits or responds to an authority. Drafts only
Execution
Recalculates exposure limits and shows where the method cannot see the new limit
REPLACES
Checking cleaning records against validated limits and hold times
PRODUCES
Changeover record exception list
NEVER
Never changes a cleaning limit or a validated method
Execution
Watches every study for the missed pull and the adverse trend
REPLACES
Tracking pull points and results by hand
PRODUCES
Stability pull schedule with missed points
NEVER
Never changes a protocol or shelf life, closes a timepoint, or files a Field Alert Report
Execution
Checks the certificate against the specification, the worksheet and the instrument that ran
REPLACES
Comparing supplier and in-house results to specification line by line
PRODUCES
CoA comparison with out-of-specification lines
NEVER
Never approves a certificate, amends a result or signs anything
Execution
Checks each inbound case against about four minimum criteria for a valid case
REPLACES
Triage of incoming safety reports for minimum criteria
PRODUCES
Case validity checklist per report (ICH E2D, EU GVP Module VI)
NEVER
Never submits to a regulator, closes a case as invalid without a person, or assigns causality
Execution
Screens literature and extracts about four criteria before anyone opens a full text
REPLACES
Manual literature screening
PRODUCES
Screened article list with relevance reasons
NEVER
Never discards a possible case without recording which criterion failed and why
Execution
Runs disproportionality analysis on a shorter cycle and shows its working
REPLACES
Periodic manual review of safety data for patterns
PRODUCES
Signal review list for the safety physician (EU GVP Module IX)
NEVER
Never validates or closes a signal, changes reference safety information, or communicates externally
Follow-up
Writes the chasing email with the facts already in it
REPLACES
Chasing owners by hand
PRODUCES
Approved follow-up email and closure log
NEVER
Never emails a regulatory authority or a customer
Follow-up
Makes the follow-up call and transcribes it into the quality system
REPLACES
Phone chasing
PRODUCES
Call transcript excerpt with the owner's commitment
NEVER
Never calls a regulatory authority or makes a commitment on your behalf
Back office
Holds the map of every system, table and field the agents may read
REPLACES
Hand-built spreadsheets linking IDs across systems
PRODUCES
Batch identity map across systems
NEVER
Never writes outside its approved transitions or exposes a masked field
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.
FAQ
What does each compliance agent do?
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Each agent replaces a specific piece of work a person is doing today.
Can I see how an agent reached its finding?
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Yes. Every agent shows its reasoning.
At what autonomy level does an agent start?
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Every agent starts at Level 1.
Can an agent promote itself to a higher autonomy level?
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No. An agent cannot promote itself.
Does an agent release a batch or file anything with an authority?
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No. The agents never release, certify or disposition a batch, and never file anything with an authority.
Can an agent send a message on its own?
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No. The agents never send a message without a named person's approval.
Send an export for one batch or lot and see the workspace run on your own data.
