From INCI ingredient to finished jar — one MoCRA-listed electronic Batch Record.
V5 Ultimate runs every step MoCRA, ISO 22716 and EU 1223/2009 care about — supplier + INCI qualification, hairnetted receiving, jacketed-vessel compounding against the locked master formula, micro + preservative-efficacy + viscosity in the LIMS, filling with the current-rev INCI / EU 1223 label, and per-lot facility + product-listing sync. The eBMR builds itself as the compounder works, and the Product Information File is a live query — not a quarterly fire drill.
Built for MoCRA, ISO 22716 Cosmetic GMP, and EU Cosmetic Regulation.
The same BMR — seen the way you run the brand.
For a cosmetics brand or contract manufacturer, the small wins compound every batch. Finance sees higher first-pass yield on expensive actives. Operations sees the next filling campaign start on time. QA and the Responsible Person see a batch record that MoCRA, the EU CPNP notification and the retailer audit already recognise.
Higher first-pass yield on expensive actives and fragrances — waste squeezed, off-spec caught mid-compound, and true cost per jar finally on the page.
- Per-batch actual cost: actives, fragrances, colourants, pack, labour and rework — visible in $, today.
- Lower active waste from earlier gating and faster in-process feedback on viscosity, pH and colour.
- Fewer rework loops from compounder errors caught at the vessel, not at final QC.
- Most cosmetics brands and co-manufacturers see V5 pay back inside year one and keep compounding.
From the supplier CoA to the filled jar — one INCI-locked thread.
Follow one batch. Every step below is a single screen in V5 — and the master-formula lockdown, INCI revision, PIF, MoCRA listing and calibration layer runs underneath them all.
Qualified supplier, current CoA + allergen declaration reconciled to the approved INCI — before a drum crosses the gowning line.
- CoA + allergen declaration verified at receipt — no CoA or expired allergen, no goods-in.
- INCI name, EC number, CAS, IFRA (fragrances) and origin checked against the approved material master.
- Every drum, IBC and pail barcoded into hygiene-segregated stores with expiry, retest date and vendor lot.
- Contract manufacturing: brand-owner / co-man split explicit on every receipt so "who is the Responsible Person" is never ambiguous.
The only formula the line can run is the version tied to the MoCRA product listing — drift from the notified composition is physically impossible.
- Master-formula lockdown — the compounder only sees the current rev tied to the live product listing and refuses substitutions.
- Two-tier weight verification (preparer + witness) at dispensing — recorded to the gram against the master formula.
- Jacketed vessel, homogeniser RPM, temperature, vacuum and pH streamed straight to the eBMR — no re-key, no clipboards.
- Compounder hard-blocked from a step they are not qualified for — ISO 22716 training enforced at the vessel.
The batch can't ship until micro, PET and every method is green — and the reviewer sees every deviation in one place.
- ISO 17516 micro limits and ISO 11930 PET wired as gates — no green, no release.
- Instrument integration for viscometer, pH meter, colourimeter, plate readers and stability chambers — results straight to the eBMR.
- Deviation / OOS / OOT linked to the affected lot, workstation and compounder — no orphan events.
- Two-independent-signature release — one from production, one from QA / Responsible Person — before the batch leaves quarantine.
One finished lot, one current-rev INCI / EU 1223 label, one Responsible-Person-signed pack — label rev = INCI rev = product listing, at the printer.
- Automated bottle / jar / tube filling with net-weight verification, torque-verified closure and tamper-evident seal.
- Current-rev INCI / EU 1223 label pinned per lot — the printer refuses to spool a superseded revision.
- Vision inspection for INCI list, allergens (Annex III), PAO symbol, batch code and Responsible Person block.
- Cartoning and pallet build reconciled to the released lot before dispatch — retailer EDI and CPNP notification pinned to the pack.
"If a fragrance allergen was just re-declared — which retailer jars are exposed?"
Every pallet ships with retailer EDI, the current INCI declaration and a pack-range manifest tied to the released lot. When a serious adverse event, IFRA allergen re-declaration, complaint or supplier NCR triggers a stop-sale, V5's lot + pack tree paints the affected pack ranges and retailers — forward from the finished lot and backward to every ingredient, fragrance, colourant and label revision that built it.
A serious adverse event report lands against a night-cream SKU — and the fragrance house simultaneously re-declares an allergen in lot FR-22110. V5 walks the tree — the finished lot that used it, the pack ranges dispatched, the retailers exposed in the US, EU and UK. Pull the lever to see the affected jars, INCI revs and PIF entries.
Vessel PM, homogeniser calibration and CIP / SIP verification — on the same tablet as production.
- PM per jacketed vessel, homogeniser, mill, pump, filler, capper and labeller.
- Calibration cycles per ISO/IEC 17025-traceable standards — balances, viscometers, pH meters, thermocouples and flow meters.
- CIP / SIP verification and water-for-cosmetics micro (aerobic, yeast + mould) tied to the release calendar.
- Change-over cleaning validation, hold-time studies and campaign sign-off enforced before the next master formula loads.
Quality, MoCRA and the Product Information File run through every batch — not stapled to the record at the end.
- Incoming inspection per raw material, active, fragrance, colourant and pack — CoA + allergen + IFRA match, sample, identity.
- In-process gates — pH, viscosity, colour, density, centrifuge stability, micro sampling plan.
- Two-signature release — one production, one QA / Responsible Person — can't be skipped before a lot leaves quarantine.
- MoCRA facility registration + product listing sync per SKU; changes flag the listing as out-of-date automatically.
- Serious Adverse Event (SAE) intake with the MoCRA 15-day clock; PIF and CPSR assembled live from released-batch data.
- Document control and training matrix — superseded SOPs, labels and lapsed ISO 22716 training hard-block the vessel.
Every quality feature in V5 — mapped to a MoCRA / ISO 22716 / EU 1223 brand.
The same platform that runs pharmaceuticals and medical devices — set up for the way a cosmetics brand or co-manufacturer actually dispenses, compounds, tests, fills, labels and releases a batch under MoCRA, 21 CFR Part 700, ISO 22716 and EU Regulation 1223/2009.
Incoming inspection & supplier qualification
Configurable per raw material, active, fragrance, colourant and pack. CoA + allergen + IFRA check, sample plan computed from lot size; a failed identity or micro raises a hold automatically.
In-process gates & ISO 22716 methods
Scheduled QC checks — pH, viscosity, density, colour, centrifuge stability, micro sampling, PET (ISO 11930), heavy-metal traces. Limits enforced; OOS opens an investigation.
Two-signature release
Production + QA / Responsible Person review-and-release before any batch ships. Every gate signed with a Part 11-equivalent e-signature — identity + meaning captured.
Deviation, OOS & MoCRA SAE
One workflow from issue raised through root cause, action, verification and close. Linked to the affected batch, eBMR, workstation, compounder and supplier — MoCRA SAE 15-day clock and EU CPNP updates built in.
Formula, INCI & label lockdown
Master Formula Records are immutable, rev-locked and tied to the current MoCRA product listing. Current-rev INCI / EU 1223 label pinned per lot — the printer refuses to spool a superseded revision, and the label rev equals the INCI rev.
Supplier scorecards & re-qualification
On-time delivery, CoA quality, deviation rate, allergen drift and audit findings rolled into a live supplier score. Expired qualifications block goods-in automatically.
Calibration & instrument qualification
Balances, viscometers, pH meters, colourimeters, plate readers, stability chambers and thermocouples on an ISO/IEC 17025-traceable calibration calendar — certificates attached, next-due enforced.
MoCRA + EU 1223 registration & PIF
Facility registration, product listing, CPSR / PIF and CPNP notification tied to each SKU and formula rev. Changes flag the listing as out-of-date and drive re-notification.
Micro, PET & stability
ISO 17516 micro limits, ISO 11930 PET and stability chamber schedules pinned to formula and pack. Water-for-cosmetics micro trending on the same calendar.
Live on your vessels, homogenisers, filling lines and label printers — no rip-and-replace.
We connect at the level your engineers and QA expect — OPC UA, Modbus, MQTT, REST, EDI, file drops, SQL. Most cosmetics manufacturers are live on day one with the vessels, homogenisers, filling and labelling lines and ERP feeds already in the plant.
Jacketed vessels & homogenisers
OPC UA and Modbus links to Fryma, Krieger, Olsa, Lee, Ginhong, Ekato and IKA. Jacket temperature, homogeniser RPM, vacuum and pH logged straight to the batch.
Filling, capping & labelling
Serac, Krones, Marchesini, IMA, Norden tube-fillers; Videojet, Domino, Markem-Imaje, Zebra thermal-transfer and print-and-apply labellers. Current-rev INCI / EU 1223 label pinned per lot at the line.
Micro, PET & stability
bioMérieux, Merck Millipore, Charles River rapid micro; PET (ISO 11930) plate readers and stability chambers (Binder, Memmert). Results wired to in-process gates.
Analytical (viscosity, pH, colour)
Brookfield / AMETEK, Anton Paar, Mettler-Toledo, HunterLab, Konica-Minolta. Viscosity, pH, density and colour results straight to the eBMR.
ERP, MES & regulatory portals
SAP, NetSuite, Microsoft Dynamics 365, Oracle, Infor. FDA MoCRA facility registration / product listing, EU CPNP notification and UK SCPN driven from released-batch data.
BI & data warehouse
Power BI, Tableau, Looker, Snowflake, Databricks. Direct SQL access to your tenant — your data, your queries, your validated reports.
MoCRA, 21 CFR Part 700, ISO 22716 & EU 1223/2009 — at the data layer.
The records build themselves as the batch is executed. When the FDA MoCRA inspector, EU competent authority or retailer auditor walks in, the evidence pack is one click — not a week of re-assembly.
Fixed-price, named team, one product family live before you pay for the next.
- Week 1–4·step 01Discovery & floor scan
We walk one product family with your team — master formulas, dispensing SOPs, compounding set-up, micro / PET methods, INCI / EU 1223 label library, MoCRA product listings, existing ERP fields. Out: a fixed scope and price.
- Week 5–9·step 02Configure & integrate
Material master, MFRs, in-process gates, LIMS methods (ISO 22716 / ISO 17516 / ISO 11930), INCI / EU 1223 label library, MoCRA listing sync, vessel / homogeniser / filling-line integrations and ERP feeds loaded. IQ / OQ on the bench.
- Week 10–13·step 03PQ, pilot & train
One product family live in pilot. Three-shift compounder training on the floor with the actual UI — not slides. PQ and UAT signed by QA, Responsible Person and operations.
- Week 14–16·step 04Go live & hyper-care
Cut over. Two weeks of hyper-care with your named delivery team on-site. KPIs published on the wall before we leave.
The first six questions on every cosmetics RFP.
How does V5 keep the plant aligned with the approved formula and the MoCRA product listing?
How does V5 handle MoCRA facility registration, product listing and serious adverse event reporting?
How does V5 handle EU Regulation 1223/2009 — PIF, CPSR, CPNP and the Responsible Person?
Will V5 talk to our vessels, homogenisers, filling and labelling lines?
We're a co-manufacturer with multiple brand-owners on one site — how does V5 keep them separate?
What about IT — Part 11-equivalent controls, GAMP 5, SOC 2, validated change control?
Book a 30-minute walkthrough with a cosmetics specialist.
We'll show a live self-building eBMR, master-formula lockdown tied to the MoCRA product listing, two-tier dispensing, in-process micro + PET + viscosity in the LIMS, current-rev INCI / EU 1223 label print at the filling line, two-signature release, a live PIF export and a mock SAE + allergen traceback — on a workspace seeded for a working cosmetics brand.
Fixed-price go-live · No platform lock-in · Onboard in 10–16 weeks