Botanical raw material · identity
Supplier COA attached · 21 CFR Part 111
FTIR fingerprintReferenceLot
- Lot rejected · supplier notifiedSupplier Quality
- Adulteration check · CAPA openedQuality
- Replacement lot · retestedMatches reference
Industries · Nutritional supplements
The supplier’s COA passed.The FTIR fingerprint didn’t.
Built for dietary-supplement brand owners and contract manufacturers under 21 CFR Part 111, where incoming identity testing, batch record completeness, and specification setting have to stay traceable, and hold up in an FDA inspection or an NSF surveillance audit.
Built for dietary-supplement GMP teams
- 21 CFR Part 111
- cGMP
- NSF
- USP Verified
- DSHEA
The decision lives in the thread, not the batch record.
Incumbents track batch and document status. Unifize reconstructs the decision trace across every function a deviation or release touched: the identity testing, the spec verification, and the reasoning an inspector actually asks for.
When the inspector is in the room, someone reconstructs it.
The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at a Part 111 inspection or an NSF surveillance audit.
Quality leadership
Every release and deviation decision stays reconstructable.
Manufacturing Operations
Incoming material release and in-process holds move on one accountable thread.
Regulatory & Label Compliance
Label claims, structure-function substantiation, and NDI notification stay tied to the evidence that supports them.
Quality Systems & Audit
Part 111 GMP evidence and NSF, USP, and Informed Sport certification records are captured where they happen.
R&D / Product Development
Blend and formulation changes move fast with their specifications and identity methods sealed to the record.
Release, suppliers, identity, complaints. One trace.
Each runs with Part 111 and your NSF or USP program built in. Start with the one that costs you most.
Quality
From the nonconformance on the floor to a CAPA closed before it ages into a 483.
- Batch Record Review & Release
- Deviation / Nonconformance
- CAPA & Effectiveness
- Audit Finding Management
Supplier Management
Supplier COAs checked against spec and tied to the lot, deeper for botanicals.
- Ingredient Supplier Qualification
- Certificate of Analysis (COA)
- Botanical Identity & Adulteration Control
Operations
Incoming identity testing held on one thread, from receipt to release.
- Incoming Identity Testing & Release
- In-Process Testing & Holds
Post-Market & Recall
Consumer complaints triaged and linked to CAPA; recalls run as one event.
- Complaint Management
- Recall Coordination
Built to sit beside the systems you already run, not to replace them.
Coexistence, not replacement
Unifize sits alongside the ERP, QMS, LIMS, and identity-testing software you already run. It replaces the ungoverned channels where the decision trace goes missing, not your systems of record.
Auditable e-signatures
Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is a record an FDA inspector or an NSF auditor can follow, not a reconstruction after the fact.
Your Part 111 questions, answered directly
Incoming identity testing (HPTLC, HPLC, FTIR), batch record completeness, specification setting and verification, and NSF or USP audit readiness are walked through with your team before anything touches a controlled record.
The moments that start a clock you don't control.
Enforcement, retailer, and audit deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.
FDA Form 483 or warning letter citing 21 CFR Part 111
Routes to CAPA & Effectiveness · owned by Quality
Batch record completeness gap found at release
Routes to Batch Record Review & Release · owned by Quality
NSF or USP surveillance-audit finding
Routes to Certification Management (NSF / USP) · owned by Quality Systems & Audit
The cost is real. It just never lands on a line you can see.
- Incoming identity testing & releaseBotanical lotOperations / Qualitymaterial on hold; an identity gap at inspection
- Deviation → CAPACA-3120Qualitycycle time; a 483 if it ages
- Batch record review & releaseReplacement lotQualitydays per lot; a completeness gap at release
- Supplier qualification & COASupplier re-qualificationSupplier Qualitydocumentation completeness; a missing certificate
- Spec setting & verificationIdentity specR&D / Qualityspecs out of sync; a spec-setting finding
Supplement makers, in their own words.
A capsule and tablet contract manufacturer and a supplement brand's quality team, on ingredient review, specs, master formulas, contract manufacturers, lot release and retained samples. Figures are as stated on film.
Erica BennermanNutritional SupplementsOne ingredient's review cut from an hour to half or less
Biovation LabsJesse Kolstad, Director of QualityRetests and labs consolidated, testing cost down 50%
Mikala HukkaNutritional SupplementsMaster formulas from approved materials, at least 50% faster
Erica BennermanNutritional SupplementsThe contract manufacturer answers inside Unifize, fast
Biovation LabsJesse Kolstad, Director of QualityLot release that took days now takes minutes
Biovation LabsJesse Kolstad, Director of QualityRetained samples tied to each lot, pulled immediately
Incumbents track the batch record. Unifize reconstructs the decision.
Pick a release or identity-testing decision you could not replay at the last inspection. We will reconstruct it live.