Formula Versioning
How Clarix handles formula versions — creating new versions of approved formulas, how batches retain their formula snapshot, and reviewing version history.
Clarix's formula versioning system ensures that approved formulas are immutable, every change creates a traceable record, and historical batches always retain an exact copy of the formula version they were manufactured under. This is a fundamental requirement for 503B GMP compliance and FDA inspection readiness.
Why formulas cannot be edited after approval
Once a formula reaches Approved status, it becomes a controlled document. Allowing direct edits to an approved formula would:
- Silently change the recipe for all future batches without a review trail
- Create ambiguity about what formula was in effect when historical batches were made
- Violate the principle of document control required by 21 CFR Part 211 and USP ⟨797⟩
Instead, Clarix requires all changes to go through a new version — a draft copy of the formula that goes through the full review and approval cycle before taking effect.
Creating a new version
You can create a new version from any Approved formula.
- Open the approved formula from the Formulas catalog.
- Click the Create new version button in the formula header.
- A confirmation dialog explains that a draft copy will be created. Click Create.
Clarix creates a new formula with:
- The same formula name and product code
- An incremented version number (e.g., if the current formula is v1, the new draft is v2)
- All BOM lines, steps, and settings copied from the approved version
- Status: Draft
You are taken directly to the new draft's detail page. The original approved version remains active and unchanged — batches can still be created from it while you work on the new draft.
Role required: Any user with the Compounder, PIC, or QA Manager role can create a new version.
Editing the new version
On the new draft version, you can make any changes needed:
- Modify product identity, BUD, storage conditions, or risk level
- Add, remove, or edit BOM lines
- Add, reorder, or reconfigure steps
- Update calculation expressions
All edits are tracked in the draft's audit log. The draft behaves exactly like a new formula draft — it must be submitted for review and approved before it can be used to create batches.
Version numbers
Versions are numbered automatically in sequential integers:
| Version | Status | Description |
|---|---|---|
| v1 | Approved | Original approved formula |
| v2 | Approved | First revision — approved after review |
| v3 | Draft | Work-in-progress revision |
Version numbers are appended to the formula number in the catalog and on printed batch records, for example: MF-2026-0001 v2.
When a new version is approved, the previous version's status changes to Superseded. Superseded formulas remain visible in the catalog (filtered as Superseded) and in the version history, but they no longer appear in the batch creation formula selector.
How batches retain formula snapshots
When a batch is created from a formula, Clarix captures a complete snapshot of the formula at that moment:
- All BOM ingredients, quantities, and ranges
- All steps with their configuration, expressions, and tolerances
- Formula attributes: BUD, storage conditions, risk level
This snapshot is stored permanently with the batch record. Even if the formula is subsequently revised or superseded, the batch record always shows exactly what version of the formula was in effect when the batch was manufactured.
This means:
- A batch created from v1 will always show the v1 BOM and steps, regardless of whether v2 or v3 was later approved.
- Investigators reviewing a batch during an audit can see the exact procedure that was authorized and followed.
- Deviations and OOS events can be traced back to the specific formula version and approved procedure.
Viewing version history
Every formula has a Version history tab that shows all versions, past and present.
- Open any formula from the Formulas catalog.
- Click the Version history tab.
The version history table shows:
| Column | Description |
|---|---|
| Version | Version number (v1, v2, …) |
| Status | Draft, Pending Review, Approved, Superseded, or Rejected |
| Changes | Brief summary of what changed from the prior version (auto-generated diff) |
| Submitted by | User who submitted for review |
| Approved by | User who approved (PIC or QA Manager name and role) |
| Approval date | Timestamp |
| Notes | Submission notes and approval or rejection comments |
Click any version row to open a read-only view of that version's full formula, including BOM and steps as they existed at the time of approval.
Comparing versions
To compare what changed between two versions:
- On the Version history tab, click the Compare button on any version row (compares that version to the immediately preceding one).
- The comparison view shows a side-by-side diff:
- BOM changes — added, removed, or modified ingredient lines highlighted in green or red
- Step changes — added, removed, reordered, or modified steps
- Attribute changes — BUD, storage, risk level if modified
This comparison is useful during re-approval review, QA audits, and when investigating whether a formula change may have contributed to a batch deviation.
Frequently asked questions
Can I have two approved versions of the same formula at the same time? No. Only one version per formula can be in Approved status at any time. When a new version is approved, the previous version is automatically moved to Superseded.
What happens to in-progress batches if a new formula version is approved? In-progress batches are not affected. A batch always uses the formula version it was started with, regardless of subsequent approvals.
Can I delete a version? No. All versions are permanently retained for audit and traceability purposes. You can archive a formula (which hides it from active catalogs) but individual versions cannot be deleted.
What if the reviewer rejects the new draft version? The new draft returns to Draft status for correction. The previously approved version (now Superseded) does not automatically become re-approved; the new version must be corrected and re-submitted.