Library
Master records that inherit
Master manufacturing records generate per formulation and per batch size, inheriting a single formulation change under change control instead of twelve records drifting apart.
IndustriesNutraceuticals
• Nutraceuticals
Identity testing enforced as a gate, not a certificate
Master manufacturing records per formulation and batch size, identity testing before dispensing, and yield measured against theoretical at every control point.
Supported frameworks, not certifications. Regulatory updates included.
Identity before issue.
- 01Sample received
- 02Identity verified
- 03Lot released
20 configured controls21 CFR Part 111 · 21 CFR Part 117 Subpart B · FSSAI health supplements
One controlled record
Why now
Every dietary ingredient
gets tested.
Section 111.75(a)(1) asks for identity testing of each dietary ingredient before use. A supplier certificate does not answer it.
- Certificates have a narrow role
They can be relied on for other components, and only after the supplier is qualified with your own confirming results.
- Master records multiply
Four products in three pack sizes means twelve master manufacturing records, not four.
- Change has to reach every one
A formulation change under change control has to land on each record that inherits it.
What is tailored
One formulation change.
Every record that inherits it.
Where the Nutraceuticals pack changes how the core behaves.
Production
Four separate signatures
Separate attribution for weighing, verifying the weighing, adding and verifying the addition — each component, every batch.
Quality
Identity testing as a gate
An untested dietary ingredient cannot be dispensed onto the floor. The test result is the gate, not a certificate.
Built for nutraceuticals
Tested before it moves.
Recorded as it happens.
These features switch on with the nutraceuticals pack, on the same ERP, MES and QMS every Factro plant runs.
01 / Quality · Identity test gate
No identity result, no dispensing.
Every dietary ingredient is sampled at receipt and tested for identity. QA releases the lot on the result, and until then the scale will not issue it to the floor.
- 01Test identity yourself.
At least one identity test runs on every dietary ingredient before use. The supplier’s certificate sits beside the result, never in place of it.
- 02Check the certificate.
Certificates are checked on intake for method, limits and actual results, and supplier qualification keeps your confirming results as evidence.
- 03See the blocker early.
Lots waiting on a test show as not issuable, so stores knows what can reach the floor before the shift starts.
02 / Library · Master records per batch size
One formulation change, every record it reaches.
Master manufacturing records are kept per formulation and per batch size. Quantities scale from one composition, and a change under change control reaches every record that inherits it.
- 01One record per batch size.
Four products in three batch sizes are twelve master records, all generated from the formulation they belong to.
- 02Scale from one composition.
Per-batch quantities come from the formulation, with any declared overage carried on the master record.
- 03Change once, reach all.
A formulation change lists every master record that inherits it, and each one moves to review together instead of drifting apart.
03 / Production · Weigh, verify, add, verify
Four signatures for every component.
Weighing, verifying the weighing, adding and verifying the addition are attributed separately for every component in every batch. Quantities adjust to each active lot’s tested potency.
- 01Four signatures, four moments.
Each of the four acts is signed on its own, with the person and the time, at the step it happens.
- 02Maker is never checker.
The person who weighed a component cannot verify it. Segregation of duties is enforced in the system, not left to the SOP.
- 03Weigh to the lot’s potency.
The quantity for an active adjusts to the tested potency of the lot being dispensed, with the calculation on the record.
04 / Production · Yield against theoretical
Yield, checked at every control point.
Each control point on the master record carries a theoretical yield with maximum and minimum deviation limits. Actual yield is recorded against it as the batch runs, and a result outside the limits starts an investigation.
- 01Theoretical, per control point.
The master record sets the theoretical yield at each point where control is necessary, with its upper and lower limits.
- 02Actual, as it happens.
Actual yield is recorded against theoretical at each control point, and as a percentage of theoretical at close.
- 03Outside the limits, investigate.
A yield outside its limits opens an investigation on the batch, with an owner, instead of waiting to be found in review.
The specification problem
Seven specifications.
Seven approvals.
Section 111.70 sets seven categories. Each one is its own approval object, with its own change history. Exports are modelled per market.
Process control points
At each point in the process where control is necessary.
Components
Identity, purity, strength, composition and contamination limits.
In-process
With documented justification, reviewed and approved by quality control.
Labels and packaging
For the labels and packaging that go onto the product.
Finished batch
Identity, purity, strength, composition and contamination limits.
Repackaging and relabelling
For product received to be repackaged or relabelled.
Final packaging and labelling
For the product as it is finally packed and labelled.
On the batch record
Tested against the version in force.
Proving a released batch was tested against the specification in force on that date is the work a document-and-spreadsheet system loses.
Exporting changes the question
United States
Part 111 governs
Section 117.5(e) exempts a compliant supplement facility from the hazard analysis and supply chain subparts, while Part 117 Subpart B manufacturing practice stays in force.
European Union
Permissibility per country
Vitamins and minerals are harmonised under Annexes I and II, but maximum levels and botanicals remain national competence. The pack models each country, not the region.
Novel foods · Regulation 2015/2283
Checked at formulation, not at customs
Without significant EU consumption before 15 May 1997, an ingredient needs authorisation. That catches a large share of Indian botanicals, so status is held on the material master.
Controls
20 controls.
6 standards.
Every control below runs on the Compliance Engine. The same record carries the evidence across the plant.
Also mappedFSSAI Schedule 4 Part II
20 controls shown for 21 CFR 111
Append-only, hash-chained audit trail capturing old value, new value, author, time and reason
Specifications across all seven Section 111.70 categories, each versioned and separately approved
Master manufacturing records generated per formulation and per batch size, inheriting a single formulation change under change control
Theoretical yield at each control point with maximum and minimum deviation limits that trigger investigation
Identity testing enforced as a gate, so an untested dietary ingredient cannot be dispensed
Supplier qualification recorded as evidence, with confirming results and periodic re-confirmation
Certificate content checked on intake for method, limits and actual results
Batch production records created for every batch, following the master record exactly
Separate attribution for weighing, verifying the weighing, adding and verifying the addition of each component
Actual yield against percentage of theoretical recorded at close
Label reconciliation and material review disposition on the same record
Declared intentional overage carried on the master record
Reprocessing documented with quality approval before and after
Quality control documentation recorded at the time of performance, not reconstructed
Role-based access control, down to the individual field
Segregation of duties enforced in the system, maker is never checker
Adverse event intake on the 15 business day clock, with six year retention applied automatically
FIFO and FEFO with hold, quarantine and release status control
Training tied to document version, reassigned on every revision
Automated redundant backup with point-in-time disaster recovery
Regulatory change
We watch the rules.
You do not have to.
The Compliance Engine tracks the rules that apply to you, works out what a change touches, updates the system and re-validates before release. You file no change request.
- • applied
21 CFR Part 111 final rule published
FDA’s current good manufacturing practice rule for dietary supplements, including the identity testing of each dietary ingredient before use.
- • applied
EU Novel Food Regulation 2015/2283 applies
A single authorisation procedure replaced the earlier novel food regime, and the pack checks authorisation status against the material master.
- • applied
Section 111.75 identity-testing gate
An untested dietary ingredient has never been dispensable in Factro — the gate was built in from the first pilot, not added after an audit finding.
- • monitoring
EU novel-food authorisation status
An ingredient without significant EU consumption history before 15 May 1997 needs authorisation under Regulation 2015/2283 before it can be sold — the pack holds authorisation status against the material master and checks it at formulation.
- • monitoring
EU permitted vitamins and minerals
Harmonised under Annexes I and II of Directive 2002/46/EC, but maximum levels and botanical substances remain national competence — the pack models permissibility per country.
Validation readiness
Controls built in,
not configured on top.
Validation packs
Available on the Dedicated tier, mapped to your workflows. URS, IQ, OQ, PQ, RTM and GAMP 5.
ISO 27001
Certification in progress. Encryption, access control and backups are described on Security & Trust.
Readiness, scored
The Compliance Engine scores inspection readiness continuously, with guidance on each open gap.
Make it your workflow
Have a requirement
to walk through?
Bring the regulation that keeps you up at night. We will show you the control that answers it, on a batch from your plant.