This article describes what Reshape Quality platform (“The platform” in this article) records for plate and run activity, how that is available. This article is intended to support customers evaluating our activity/audit capabilities against their requirements (most commonly against 21 CFR pt 11).
Overview
The platform captures two broad categories of activity:
System activity — events generated automatically by the platform as records are generated, with no user action required.
User activity — events generated by a user or administrator
System Activity
The following events are recorded automatically whenever the underlying record changes:
Plate processed
Barcode scanned
Plate image capture
Plate analyzed
Plate sorted
Batch start
Batch end
Device heartbeat and connectivity are also recorded, but as a separate stream from plate/run activity and used for uptime monitoring, not part of the sample audit trail.
User Activity
The user-driven activity that is possible and tracked in the platform is
Manual edits of analysis results. The edit doesn’t override the automated analysis output, but is stored separately along with edit reason and audit trail.
Data export events
Generating barcodes through sample tracking workspace
For non-barcode workflows: Setting the active analysis
What's captured for each user activity
Field | Captured? |
Which field/property was changed (if applicable) | Yes |
Previous value (if applicable) | Yes |
New value (if applicable) | Yes |
Timestamp | Yes |
User/profile | Yes |
Reason for change (user-entered) (if applicable) | Yes — stored per property |
How to access the audit log
Plate Activity view:
At the individual plate level, a log is shown with:
Plate registration timepoint
User edits made
Via the external API/available to LIMS integration, for edited analysis properties:
Original value
Corrected value
Correction reason
User who did correction
Timestamp
Audit log page:
All activities sequentially listed in chronological order with fields