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Formulation lifecycle, batch manufacturing records (BMR), stability testing, adverse event logging & streamlined UX
The US FDA Modernization of Cosmetics Regulation Act (MoCRA 2022) and ISO 22716 cGMP mandate rigorous batch record keeping, ingredient safety substantiation, and mandatory adverse event reporting. Novaqis equips personal care, skincare, and beauty brands with an agile formulation repository, digital compounding batch records, microbiology and stability testing worksheets, and QMS adverse event registers. Operators enjoy fast, 1-click approvals on the shop floor without legacy pharmaceutical software bloat.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Manage base formulations, active concentrations, preservative systems, and fragrance versions with full audit history and automated side-by-side ingredient difference tracking.
Capture customer skin sensitivity reports, photos, and lot numbers in Novaqis QMS. Automatically triage serious adverse events with 15-day FDA electronic reporting deadlines.
Automate USP <51> Antimicrobial Effectiveness Testing (AET), accelerated temperature chamber stability (37°C, 45°C), viscosity drift curves, and emulsion separation checks.
Ensure compounding kettles and filling lines are sanitized and hold times are respected using Novaqis eLog™ with real-time countdown meters and fail-closed readiness interlocks.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Centralized document repository connecting toxicological profiles, CoA tests, and clinical patch test data.
Real-time verification of raw batch ingredients, lot numbers, homogenization speeds, and cooling curves.
Single-click approvals for high-throughput filling and packaging lines with background immutable audit logging.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Achieve full compliance with US FDA MoCRA 2022 and ISO 22716 Cosmetics cGMP
Replace paper compounding log sheets with digital step execution and barcode verification
Reduce formulation scale-up time and new product launch cycles by up to 40%
Eliminate signature fatigue with 1-click lean operator sign-offs on filling and capping lines
FAQ
