From identity-tested ingredient to finished bottle — one 21 CFR 111 electronic Batch Production Record.
V5 Ultimate runs every step 21 CFR Part 111, FSMA Part 117 and NSF/ANSI 455-2 audits care about — supplier + ingredient identity qualification, hairnetted receiving, V-blender / granulation / tablet-press against the locked Master Manufacturing Record, HPLC + FTIR + micro + heavy-metal identity in the LIMS, encapsulation and bottle filling with the current-rev Supplement Facts label, and a per-batch self-building Batch Production Record. The BPR builds itself as the operator works, and label claims are a live query off the released formula — not a marketing spreadsheet.
Built for 21 CFR 111, FSMA, and NSF/USP certification audits.
The same BPR — seen the way you run the brand.
For a dietary supplement brand or contract manufacturer, the small wins compound every batch. Finance sees higher first-pass yield on expensive botanical extracts. Operations sees the next campaign start on time. QA sees a batch record that a 21 CFR 111 inspector, an NSF/ANSI 455-2 audit or an Amazon Brand Registry review already recognise.
Higher first-pass yield on expensive botanicals and actives — over-dose waste squeezed, off-spec caught mid-blend, and true cost per bottle finally on the page.
- Per-batch actual cost: botanicals, actives, capsules, pack, labour and rework — visible in $, today.
- Lower over-dose waste from earlier gating and faster in-process HPLC / blend-uniformity feedback.
- Fewer rework loops from dispensing errors caught at the vessel, not at final QC.
- Most supplement brands and co-manufacturers see V5 pay back inside year one and keep compounding.
From the supplier CoA + identity retest to the sealed bottle — one MMR-locked thread.
Follow one batch. Every step below is a single screen in V5 — and the Master Manufacturing Record lockdown, Supplement Facts label revision, NSF/ANSI 455-2 evidence pack and calibration layer runs underneath them all.
Qualified supplier, current CoA reconciled to a V5 identity retest — before a drum crosses the gowning line.
- CoA + identity retest verified at receipt — no identity pass, no goods-in release.
- Botanical name, part-used, extraction ratio, marker compound and origin checked against the approved material master.
- Heavy metals (Pb, As, Cd, Hg per USP <2232>), micro (USP <2021> / <2022>) and pesticide screens tied to the material spec.
- Contract manufacturing: brand-owner / co-man split explicit on every receipt so the "own-label distributor" trail is never ambiguous.
The only formula the line can run is the approved Master Manufacturing Record — drift from the reviewed MMR is physically impossible.
- MMR lockdown — the operator only sees the current rev tied to the live Supplement Facts label and refuses substitutions.
- Two-tier weight verification (preparer + witness) at dispensing — recorded to the gram against the MMR.
- V-blender RPM, blend time, tablet-press force / weight / hardness, capsule fill-weight and coating temp streamed straight to the eBPR — no re-key.
- Operator hard-blocked from a step they are not qualified for — 21 CFR 111 subpart D training enforced at the vessel.
The batch can't ship until identity, potency and every 21 CFR 111 spec is green — and the QA reviewer sees every deviation in one place.
- 21 CFR 111 subpart E identity + potency + component spec wired as gates — no green, no release.
- Instrument integration for HPLC, UPLC, ICP-MS, FTIR, dissolution, Karl-Fischer, plate readers and stability chambers.
- Deviation / OOS / OOT linked to the affected batch, workstation and operator — no orphan events per 21 CFR 111.140.
- Two-independent-signature release — one from production, one from QA — before the batch leaves quarantine per 21 CFR 111.123.
One finished lot, one current-rev Supplement Facts label, one QA-signed pack — label claim = released formula, at the printer.
- Automated capsule / tablet counter + net-weight verification, torque-verified cap and tamper-evident induction seal.
- Current-rev Supplement Facts label pinned per lot — the printer refuses to spool a superseded revision.
- Vision inspection for Supplement Facts panel, %DV table, allergens, best-by date and NDC-style SKU.
- Cartoning and pallet build reconciled to the released lot before dispatch — retailer EDI, Amazon FBA prep and DSCSA-style serial where required.
"If a botanical ingredient just failed retest — which retailer and Amazon FBA bottles are exposed?"
Every pallet ships with retailer EDI, the current Supplement Facts panel and a pack-range manifest tied to the released bottle lot. When an ingredient OOS retest, a serious adverse event report, a supplier NCR or an Amazon Brand Registry challenge triggers a stop-sale, V5's lot + pack tree paints the affected pack ranges and destinations — forward from the finished lot and backward to every ingredient, capsule, closure and label revision that built it.
A retest on ashwagandha extract lot AW-4418 comes back out-of-spec on withanolides. V5 walks the tree — the finished bottle lot that used it, the pack ranges dispatched, the retailers and Amazon FBA shipments exposed. Pull the lever to see the affected bottles, MMR revs and BPR entries.
V-blender PM, tablet-press tooling and CIP verification — on the same tablet as production.
- PM per V-blender, granulator, dryer, tablet-press, capsule filler, coating pan and bottle line.
- Calibration cycles per ISO/IEC 17025-traceable standards — balances, tablet hardness testers, Karl-Fischer, pH meters and thermocouples.
- CIP verification and USP purified-water micro (aerobic, yeast + mould) tied to the release calendar.
- Change-over cleaning validation, hold-time studies and campaign sign-off enforced before the next MMR loads.
Quality, 21 CFR 111 and the NSF audit run through every batch — not stapled to the record at the end.
- Incoming inspection per ingredient, capsule, coating and pack — CoA + identity retest per 21 CFR 111.75.
- In-process gates — blend uniformity, tablet weight / hardness / friability, capsule fill-weight, dissolution, moisture per USP <2091>.
- Two-signature release — one production, one QA — can't be skipped before a lot leaves quarantine per 21 CFR 111.123.
- Serious Adverse Event (SAE) intake per 21 CFR 190 with the 15-day clock; FDA 806 correction and removal drafted live.
- NSF/ANSI 455-2 GMP evidence, USP <2750> MMR / BPR and Amazon Brand Registry requests answered from released-batch data.
- Document control and training matrix — superseded SOPs, labels and lapsed 21 CFR 111 training hard-block the vessel.
Every quality feature in V5 — mapped to a 21 CFR 111 / NSF/ANSI 455-2 brand.
The same platform that runs pharmaceuticals and medical devices — set up for the way a dietary supplement brand or contract manufacturer actually dispenses, blends, granulates, tests, encapsulates, bottles and releases a batch under 21 CFR Part 111, FSMA Part 117, NSF/ANSI 455-2 and USP <2750>.
Incoming inspection & ingredient identity
Configurable per ingredient, active, capsule, coating and pack. CoA + in-house identity retest (FTIR, HPLC, TLC) per 21 CFR 111.75; a failed identity or micro raises a hold automatically.
In-process gates & USP methods
Scheduled QC checks — blend uniformity, tablet weight / hardness / friability, capsule fill-weight, dissolution, moisture, heavy metals (USP <2232>), micro (USP <2021>). Limits enforced; OOS opens an investigation.
Two-signature release
Production + QA review-and-release before any batch ships. Every gate signed with a 21 CFR Part 11 e-signature — identity + meaning captured per 111.123.
Deviation, OOS, SAE & FDA 806
One workflow from issue raised through root cause, action, verification and close. Linked to the affected batch, eBPR, workstation, operator and supplier — SAE 15-day clock (21 CFR 190) and FDA 806 correction/removal built in.
MMR & Supplement Facts lockdown
Master Manufacturing Records are immutable, rev-locked and tied to the current Supplement Facts panel. Current-rev label pinned per lot — the printer refuses to spool a superseded revision, and the label rev equals the MMR rev.
Supplier scorecards & re-qualification
On-time delivery, CoA quality, identity retest pass-rate, deviation rate and audit findings rolled into a live supplier score. Expired qualifications block goods-in automatically.
Calibration & instrument qualification
Balances, tablet hardness testers, Karl-Fischer, HPLC / UPLC / ICP-MS / FTIR, dissolution baths, disintegration and stability chambers on an ISO/IEC 17025-traceable calibration calendar.
NSF/ANSI 455-2 & USP <2750> evidence
GMP evidence pack — MMR + BPR + component identity + finished testing + label reconciliation — assembled on demand from released-batch data. NSF audit and USP verified requests answered in minutes.
Stability & shelf-life
ICH-style stability chambers scheduled per formula and pack. Long-term (25°C / 60% RH), intermediate (30°C / 65% RH) and accelerated (40°C / 75% RH) pull-points tied to formula and pack.
Live on your blenders, tablet presses, encapsulators 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 supplement manufacturers are live on day one with the blenders, tablet presses, capsule and bottle lines and ERP feeds already in the plant.
Blenders, granulators & dryers
OPC UA and Modbus links to Patterson-Kelley, Gemco, Munson, GEA, Glatt, LB Bohle, Bosch, Fitzpatrick. Blend RPM, blend time, granulation end-point and fluid-bed inlet temp logged straight to the batch.
Tablet presses & capsule fillers
Fette, Korsch, Kikusui, Manesty, ACG rotary tablet presses; Bosch GKF, MG2, IMA Zanasi and ACG capsule fillers. Force, weight, hardness, friability and capsule fill-weight streamed to the eBPR.
Bottle fill, cap, seal & label
IMA, Bosch, Kirby Lester and Cremer counters; Enercon induction sealers; Videojet, Domino, Markem-Imaje, Zebra thermal-transfer and print-and-apply labellers. Current-rev Supplement Facts label pinned per lot.
Identity, potency & micro
Agilent, Waters, Shimadzu, Thermo HPLC / UPLC / ICP-MS; Bruker / PerkinElmer FTIR; bioMérieux, Merck Millipore rapid micro. Results wired to in-process and release gates.
ERP, MES & retail portals
SAP, NetSuite, Microsoft Dynamics 365, Oracle, Infor. FDA facility registration, Amazon Brand Registry / Vendor Central, retailer EDI (Costco, Walmart, GNC, Vitamin Shoppe) 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.
21 CFR Part 111, FSMA, Part 11, NSF/ANSI 455-2 & USP <2750> — at the data layer.
The records build themselves as the batch is executed. When the FDA 111 inspector, NSF auditor or Amazon Brand Registry reviewer 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 — MMRs, dispensing SOPs, blender / press / encapsulator set-up, identity + potency + micro methods, Supplement Facts label library, existing ERP fields. Out: a fixed scope and price.
- Week 5–9·step 02Configure & integrate
Material master, MMRs, in-process gates, LIMS methods (21 CFR 111 / USP <2091> / USP <2232>), Supplement Facts label library, blender / press / encapsulator / bottle-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 operator training on the floor with the actual UI — not slides. PQ and UAT signed by QA 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 supplements RFP.
How does V5 keep the plant aligned with the approved MMR and the Supplement Facts label?
How does V5 handle 21 CFR 111 ingredient identity, in-process testing and finished-batch release?
How does V5 handle Serious Adverse Event (SAE) reporting under 21 CFR 190 and FDA 806 correction and removal?
Will V5 talk to our V-blenders, tablet presses, encapsulators and bottling lines?
We're a contract manufacturer with multiple brand-owners on one site — how does V5 keep them separate?
What about IT — 21 CFR Part 11, GAMP 5, SOC 2, validated change control?
Book a 30-minute walkthrough with a supplements specialist.
We'll show a live self-building eBPR, MMR lockdown, two-tier dispensing, in-process HPLC identity + potency + micro in the LIMS, current-rev Supplement Facts label print at the bottling line, two-signature release, a live NSF/ANSI 455-2 evidence export and a mock ingredient-OOS traceback — on a workspace seeded for a working supplements brand.
Fixed-price go-live · No platform lock-in · Onboard in 10–16 weeks