Layout Approval and Archive

Approve Batch Record Layouts with electronic signature, archive superseded layouts, and understand per-batch layout snapshots.

Batch Record Layouts must be approved before they can be selected when creating a new batch. Approval locks the section configuration for operational use and triggers version control when a new approval supersedes an older layout.

Approve a layout

Open a Draft layout at /batch-templates.
Review section visibility, order, and required flags in the configurator.
Click Approve.
Enter your facility PIN when prompted (electronic signature under 21 CFR Part 11).
Confirm approval.

After approval:

Status changes to Approved
The layout appears in the batch creation form for its linked formula
A new batch selecting this layout receives a layout snapshot — frozen copy of section keys, labels, order, and visibility

Per-batch layout snapshot

When a batch is created, Clarix copies the approved layout's sections into the batch record. This snapshot:

Preserves the EBR structure even if the template is later edited or archived
Powers the Batch Record Layout panel on the batch detail page
Drives Download MBR and Download Custom EBR section ordering

Operators can rearrange visible sections on an individual batch (where permitted) without changing the master layout template. Batch-level changes are logged separately from template edits.

Superseded layouts

Approving a new layout for the same formula and name pattern may mark a prior approved version as Superseded. Superseded layouts remain visible in the catalog for audit reference but cannot be selected for new batches.

Always verify which layout version is active before starting production for a product family.

Archive a layout

Archive layouts that are no longer used (discontinued products, retired procedures):

Open an Approved or Draft layout.
Click Archive.
Confirm with your facility PIN.

Archived layouts cannot be selected for new batches. Existing batches that already snapshot the layout are unaffected.

Role requirements

Action	Minimum role
Approve layout	PIC or QA Manager
Archive layout	PIC or QA Manager
Rearrange sections on an active batch	Supervisor or above (batch-level)

Regulatory reference

21 CFR Part 11 — Approval of Batch Record Layouts requires authenticated electronic signature (facility PIN). The per-batch snapshot provides a point-in-time record of which EBR sections were in effect when production began, supporting batch record integrity under 21 CFR 211.188.