Supplements · QMS
QMS for supplement manufacturers
QMS for supplement manufacturers. Specifications, certificates of analysis, micro and heavy metal results, deviations, CAPAs and release status on the same batch record.
Today
A batch is finished, boxed and blocking a bay while someone works out which results are still outstanding.
Document-led quality systems store the certificate. They don't know which formulation version, active batch or specification the result should be judged against, so release becomes a manual reconciliation.
With Worldover
Worldover QMS connects specifications, sampling plans, test results, certificates of analysis, deviations and CAPAs to the batch, the formulation version and the materials behind it.
Release is a status anyone can see, with every outstanding test, signature and deviation listed against the batch.
What's in it
What QMSdoes inside Worldover.
The operational outcomes come first. Open any area to inspect the underlying controls, records and technical detail.
Standards and regimes
01Testing ManagementTest protocols, scheduling, results and approvals with full audit trail.
Test protocol library
Pre-built and customisable protocols (stability, compatibility, microbial and others) with configurable parameters and pass/fail criteria.
Test scheduling
Schedule tests against formulations, raw materials and finished products, with status tracking and automated reminders.
Results management
Record and approve results with a full audit trail, linked back to formulations, products and batches.
Approval workflows
Configurable approvals with role-based sign-off.
Test reporting
Reports for internal QA and external regulatory submission.
Integration with formulation and PLM
Results feed release decisions and regulatory documentation directly.
02QMSTraining, document control and CAPA. Supports FDA 21 CFR Part 11.
Training
Monitor training for individuals and the team as a whole as the operation scales.
Auto-reminders
Automatic reminders for outstanding training items.
Document control
Change management across SOPs, batch documentation, training records and health and safety, with 21 CFR Part 11 electronic records and a full audit trail.
CAPA reporting
Customisable CAPA covering corrective and preventive actions, deviations and change control, supporting 21 CFR Part 111 record-keeping.
One workflow, end to end
A recall question on a Friday afternoon
The difference isn't another isolated tool. It's the same work running from one live record.
Where work breaks
Certificates arrive as PDFs
Supplier results are checked by eye against a specification held somewhere else, so a mismatch depends on who's reading.
Deviations live apart from the product
A deviation log tells you something happened, not which products, batches and customers it touches.
Traceability is rebuilt on demand
When a recall question lands, the chain from active batch to finished pallet is reassembled from several systems under time pressure.
- 01
A supplier reports a heavy metal excursion on one lot of a botanical extract.
- 02
Today: quality pulls goods-in records, blending sheets and dispatch notes to work out where that lot went.
- 03
In Worldover: the material lot links forward to every blend, batch, pallet and customer delivery.
- 04
Retained samples, test results and release decisions for each affected batch are already attached.
- 05
The customer notification list and the evidence pack are produced from the record rather than assembled by hand.
With Worldover
- 1
Specifications come from the approved version
Release criteria are derived from the formulation version being made, not from a separate quality document.
- 2
Results land against the batch
In-house and third-party results, certificates and micro data attach to the batch and the material lot they judge.
- 3
Deviations carry their impact
Every deviation shows the batches, products and customers involved, with the CAPA tracked to close.
- 4
Release is explicit
Outstanding tests, signatures and open deviations are visible, so nothing is released on assumption.
Connected inside Worldover
One product workflow.Every consequence connected.
Because material lots, potency and assay live on the substance record, quality judges a result against the version and lot it belongs to. That's what makes forward and backward traceability a query instead of a project.
Willow
Useful AI starts with live operational context.
Scoped permissions, human approval for anything material and a full audit trail of every action.
- Which batches can't be released today, and what's outstanding on each?
- Where did this active lot end up, down to customer delivery?
- Which deviations on this product line are still open after 30 days?
Buyer confidence
A specialist system, without a specialist-system rollout.
Worldover combines detailed operational control with a practical route to a live first phase.
- 50+
- Enterprise customers across cosmetics, chemicals and supplements
- 4 to 7
- Point systems typically retired, most within 6 months of go-live
- 12 to 16 weeks
- To a live Phase 1, not a multi-year programme
- 1 record
- Per substance, everywhere it appears
See it on your operation
Book a 30-minute slot
Give us the essentials, then choose a 30-minute slot directly in the right person’s calendar. We’ll use your workflow, products and documents, not a generic slide deck.