Compliance Logger
Auto-generates FDA 21 CFR Part 11 audit trail entries from operational events.
RunningComplianceCloud runtimeOwned by Priya Shah
Configuration for Compliance Logger. Changes deploy on save.
Identity
- Name
- Compliance Logger
- Description
- Auto-generates FDA 21 CFR Part 11 audit trail entries from operational events.
- Category
- Compliance
- Owner
- Priya Shah
Trigger
- Type
- Continuous
- Detail
- audit topics
Instructions
Watch for vibration on rotating equipment via the MQTT bearing topic. When 5-minute moving average exceeds the ISO 10816 alert threshold for the equipment class, run a spectral analysis. If signature matches a known wear pattern, project the time-to-failure and draft a work order with: parts lookup, schedule reservation, parts reservation, and estimated cost. Submit for approval if cost > $200 or downtime > 1 hour.
Tools enabled
Query tagsSpectral analysisKnowledge searchInventory APISchedule lookupCreate work orderSend notification
Approval policy
- Mode
- Approve when cost > $200
- Approvers
- Sam Rivera, Marcus Liu
- Auto-decline after
- 24 hours