From COA-verified receipt to sealed vet carton — one DSCSA + FDA CVM traceability-ready batch record with approved NADA carton label that matches the bag.
V5 Ultimate runs every step your regulated-manufacturer customers audit — Approved Supplier + FSVP qualification, barcode-scanned receipt of every super-sack, gravimetric dispense against the locked formula, ribbon-blender uniformity, moisture / aw / particle size / micro in the LIMS, per-customer release specs, kosher / halal / organic / non-GMO chain of custody, and an auto-generated current-rev approved NADA/ANADA label with lot, expiry, withdrawal time and NDC/serial on the approved carton and label artwork, and a DSCSA + FDA CVM traceability traceability record ready in seconds. No paper batch sheets, no drift between the label and the batch, no recall panic.
Built for 21 CFR 210/211, FDA CVM oversight, ICH Q7, EU Annex 11, and PIC/S GMP.
The same batch record — seen the way you run the plant.
For a B2B finished dosage form, treat or wet-food maker, the small wins compound with every super-sack. Finance sees higher yield on premium APIs and specialty combination products. Operations sees the next changeover clear the allergen and sanitation swab on time. Quality sees a CoA your customer's incoming QA will accept without a phone call.
Higher first-pass yield on premium APIs and specialty combination products — dispense drift squeezed, customer rejections killed, and true cost per carton finally on the page.
- Per-batch actual cost: proteins, grains, premixes, packaging, labour and rework — visible in $, today.
- Lower giveaway from gravimetric dispense and in-line tablet weight uniformity checks — no over-dispense of expensive API.
- Fewer FDA / state feed-control findings from label-vs-batch drift and missing DSCSA + FDA CVM traceability KDEs.
- Most veterinary pharma sites see V5 pay back inside year one and keep compounding.
From the FSVP-qualified API lot to the sealed vet carton & DSCSA + FDA CVM traceability traceability record — one formula-locked thread.
Follow one blend. Every step below is a single screen in V5 — and the FDA CVM cGMP, allergen matrix, kosher / halal / organic chain of custody and customer-specific spec library run underneath them all.
Qualified grower, verified API lot, certification chain intact — before a pound reaches the granulator / tablet press.
The only formula the line can run is the released, QA-approved MMR version — drift from the approved NADA label spec is physically impossible.
The batch can't ship until every approved NADA label attribute is green — and the reviewer sees every OOS in one place.
One finished batch, one current-rev approved NADA label, one QA-signed bag — no drift between the bag and the batch.
"If a supplier just flagged E. coli O157:H7 — which retailers, DCs and e-commerce FCs are exposed?"
Every pallet ships with the batch record, GS1-128 SSCC, chain-of-custody marks and a serialised carton manifest tied to the released blend lot. When a supplier flag, a customer complaint or an FDA CVM cGMP event triggers a stop-sale, V5's lot + carton tree paints the affected bag ranges and destinations — forward from the finished blend and backward to every input powder, premix, flavour and packaging lot that built it. A CoA retraction with the recall-notice pack drafts itself.
A supplier COA flags an OOS related-substance on romaine leaf lot CM-6640. V5 walks the tree — the finished chewable and injectable batches that used it, the carton ranges dispatched, the retail DCs, foodservice DCs and independent clinics exposed. Pull the lever to see the FSMA 204 sortable spreadsheet assemble itself.
Granulator / tablet press PM, grinder verification, dust collection & Master Sanitation Schedule — on the same tablet as production.
Quality, FSMA cGMP + FDA CVM oversight and approved-label control run through every batch — not stapled to the record at the end.
Every quality feature in V5 — mapped to a veterinary pharmaceutical manufacturer.
The same platform that runs pharmaceuticals and human food — set up for the way a veterinary drug manufacturer actually receives, preconditions, extrudes, coats and dries, tests, bags-off and releases a batch under 21 CFR 210/211 + 21 CFR 226, DSCSA + FDA CVM traceability, FSVP, FDA CVM Model Regulations and GFSI (SQF, BRCGS, FSSC 22000).
Approved Supplier Program & FSVP
Configurable per powder, premix, flavour and pack. CoA + FSVP + kosher / halal / organic verified at receipt; expired qualification blocks goods-in automatically.
Gravimetric dispense & uniformity
Loss-in-weight feeders and gravimetric dispense verify API and each excipient to the gram against the MMR. Tablet weight uniformity samples pull along the product stream — an OOS uniformity opens a deviation.
Two-signature release
Production + QA review-and-release before any blend ships. Every gate signed with a validated e-signature — identity + meaning captured.
Deviation, complaint & customer feedback
One workflow from issue raised through root cause, action, verification and close. Linked to the affected blend, workstation, operator, supplier and customer — customer complaint routes to the correct account team.
Formula & approved-label lockdown
Formulas are immutable, rev-locked and tied to the current-rev approved NADA/ANADA label with lot, expiry, withdrawal time and NDC/serial. The approved carton and label artwork engine refuses to render a superseded GA — the line cannot bag with an out-of-date label.
Supplier scorecards & re-qualification
On-time delivery, CoA quality, FSVP status, GFSI certification, deviation rate and audit findings rolled into a live supplier score. Expired qualifications block goods-in automatically.
Organic, non-GMO, grain-free & humanely-raised chain of custody
Certification and marketing claims (Organic 7 CFR 205, non-GMO Project, grain-free, humanely raised) carried lot-by-lot from receiving through granulate & compress, coating, packaging and shipping — with mass-balance evidence enforced at each step.
approved NADA label proofing & guaranteed-analysis roll-up
V5 rolls up the batch's proximate, vitamin and mineral results into the printed bag's approved NADA/ANADA label with lot, expiry, withdrawal time and NDC/serial. A GA drift triggers a re-approved label proof before the next bag can print.
Retain samples & stability
Retain samples booked into the retain library per lot with location, disposition and expiry. Stability studies scheduled per blend and pack — appearance, moisture, aw, assay and micro pull-points tied to formulation.
Live on your granulation / compression lines, feeders, coating pans and packaging lines — no rip-and-replace.
We connect at the level your engineers and QA team expect — OPC UA, Modbus, MQTT, REST, EDI, file drops, SQL. Most plants are live on day one with the granulation / compression lines, fluid bed dryers, coating drums, gravimetric feeders, sifters, metal detectors, checkweigher + vision inspections, bottle fillers, blister packers and cartoners and packaging lines already installed.
Granulate & compress, dispense & grinding
OPC UA and Modbus links to Wenger, Bühler, Clextral, Extru-Tech granulation & compression lines and sort tables; K-Tron, Coperion, Schenck, Acrison loss-in-weight and gravimetric feeders; Bühler and CPM sifters; Sweco and Russell Finex sifters. Screw speed, barrel temperature, moisture, SME and dispensed mass logged straight to the batch.
Magnets, metal detect & checkweigh
Bunting and Eriez magnets; Mettler-Toledo Safeline, Loma, Anritsu, Ishida metal detectors and checkweigher + vision inspections. Reject events, test-piece verifications and giveaway data streamed to the batch — a failed verification hard-stops the line.
Bag-off, FIBC fill & label
Concetti, Premier Tech, Haver & Boecker, Choice Bagging carton and FIBC fillers; Videojet, Domino, Markem-Imaje, Zebra thermal-transfer and print-and-apply labellers. Current-rev FDA CVM guaranteed-analysis bag artwork and lot code pinned per carton at the line.
Lab instruments & LIMS
NIR, HPLC, FTIR, ICP-MS, LC-MS/MS, moisture analyzer, aw meter, bomb calorimeter, finished dosage form hardness tester, texture analyzer. Direct connectors for Waters, Agilent, Thermo Scientific, PerkinElmer, Mettler-Toledo, HunterLab and Malvern Panalytical.
ERP, WMS & customer portals
SAP, NetSuite, Microsoft Dynamics 365, Oracle, Infor, JustFood, Aptean. Retailer EDI (MWI Animal Health, Patterson Vet, Covetrus, Henry Schein Animal Health), ASN and DSCSA + FDA CVM traceability traceability exports per retailer preference — email, SFTP, portal upload or API.
BI & data warehouse
Power BI, Tableau, Looker, Snowflake, Databricks. Direct SQL access to your tenant — your data, your queries, your validated reports.
21 CFR 210/211 + 21 CFR 226, DSCSA + FDA CVM traceability, FDA CVM & GFSI — at the data layer.
The records build themselves as the blend is executed. When the FDA FSMA inspector, an SQF / BRCGS / FSSC 22000 auditor or a state feed control official 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 — formulas, approved NADA/ANADA label with lot, expiry, withdrawal time and NDC/serial library, approved carton and label artwork, allergen matrix, organic / non-GMO / humane certifications, existing ERP and WMS fields. Out: a fixed scope and price.
- Week 5–9·step 02Configure & integrate
Material master, formulas, approved NADA label per SKU, LIMS methods (proximate, related substances, vitamin/mineral assay, endotoxin), approved carton and label artwork templates, granulator / tablet press / dryer / coating pan / feeder / metal-detector / carton integrations and ERP feeds loaded.
- Week 10–13·step 03Pilot & train
One product family live in pilot. Three-shift operator training on the floor with the actual UI — not slides. UAT signed by QA, production 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 veterinary pharma RFP.
How does V5 keep the approved NADA/ANADA label with lot, expiry, withdrawal time and NDC/serial on the bag in sync with the batch actually made?
How does V5 handle FDA CVM cGMP and FSVP for imported ingredients?
How does V5 handle DSCSA + FDA CVM traceability traceability KDEs and CTEs for a veterinary pharma lot?
Will V5 talk to our granulation / compression lines, fluid bed dryers, coating pans, metal detectors and packaging lines?
We contract-manufacture private-label veterinary pharma for multiple brands on one line — how does V5 keep them separate?
What about IT — validated change control, SOC 2 and GFSI / certifying-body audit prep?
Book a 30-minute walkthrough with a veterinary pharma specialist.
We'll show a live self-building batch record, formula lockdown, gravimetric dispense and process-parameter capture (impeller speed, spray rate, LOD, compression force), assay (UHPLC), related substances, dissolution, uniformity of dosage units, water content (KF), microbial limits (USP <61>/<62>) and endotoxin (LAL) in the LIMS, two-signature release, current-rev approved-label lockdown at carton and a mock supplier OOS related-substance traceback — on a workspace seeded for a working veterinary pharma site.
Fixed-price go-live · No platform lock-in · Onboard in 10–16 weeks