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Master Manufacturing Records (MMR), raw botanical testing, allergen controls, and adaptive lean e-signatures
Nutraceutical, dietary supplement, and functional food manufacturers must guarantee formula consistency, label claim potency, and heavy metal screening without getting paralyzed by pharmaceutical red tape. Novaqis combines 21 CFR Part 111 Master Manufacturing Records (MMR), raw botanical lot testing in LIMS, heavy metal and pesticide testing worksheets, and allergen segregation with policy-driven signature gating—enabling 1-click streamlined approvals on routine blending while retaining strict cryptographic sign-offs on release testing.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Enforce exact ingredient ratios, pre-weigh dispensing verification with barcode scanning, and moisture/potency adjustments. Eliminates paper batch binders while cutting operator transcription errors.
Test raw herbs, vitamins, and minerals against USP and AOAC monographs: HPLC potency assays, Karl Fischer moisture, ICP-MS heavy metals (Pb, As, Cd, Hg), and microbiology plate counts.
Track equipment cleaning verification, allergen changeover swabs, and clean hold time (CHT) countdowns in Novaqis eLog™, preventing cross-contact contamination across production runs.
Remove repetitive password re-entry for high-volume capsule filling and tableting steps. Switch to 1-click session-bound approvals while preserving full ALCOA+ audit trails and individual accountability.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Standardized digital recipe formulation with tolerance bounds and dispensing mass-balance checks.
Dynamic LIMS worksheets with automatic pass/fail threshold flags for Lead, Arsenic, Cadmium, and Mercury.
Toggle between 21 CFR Part 11 cryptographic ceremony and frictionless 1-click approvals based on risk tier.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Achieve turnkey compliance with US FDA 21 CFR Part 111, NSF/ANSI 173, and FSSAI standards
Reduce batch disposition and Certificate of Analysis (CoA) release cycles from 4 days to under 2 hours
Eliminate operator signature fatigue by replacing repetitive password re-entry with 1-click lean approvals
Gain complete First-Expiry, First-Out (FEFO) raw material lot traceability from farm source to bottle
FAQ
