Nutraceuticals & Supplements

– AI-empowered cGMP for nutraceuticals—without heavyweight overhead
– Link Quality Events → CAPA → Controlled Change → Documents/Training across brands, SKUs, and lots—hosted in-region with committed uptime.

Complaints, deviations/NCRs, and adverse events scattered across spreadsheets and email.
Slow investigations → delayed remediation and recurring issues.
Supplier COAs/specs and in-process tests not tied to changes, docs, or training.
Label/packaging/formulation changes that don’t roll into SOPs and training.
Approval ping-pong and poor visibility for contract manufacturers/labs.

Quality Events intake → investigation → QA review → closure (product, batch/lot, site, market).
CAPA with root-cause tools and action types: user task / make new document version effective / assign training & require completion; closure dependencies enforce sequence and evidence.
Controlled Change for formulation/label/packaging/processing with impact & risk, stage gates, and closure dependencies (implementation tasks, verifications, linked doc releases/training).
Document Control & Training — versioned SOPs/specs, e-sign, Read-&-Understood; auto-assign training on release
AI-empowered (assistive) summaries & suggested fields/checklists (you approve).
Preliminary Reviewer gate to prevent reject→resubmit loops.
External Notification Recipient for partners/suppliers (read-only links) to inform relevant stakeholders in real-time and avoid external tool based communication.
Cross-linking across Quality Events ↔ CAPA ↔ Controlled Change ↔ Documents/Training.
Version and audit diffs, no hard deletion and restore, and configurable labels to adapt to your organisation’s terminology.
In-region data residency (USA • EU • APAC • Middle East • ANZ) and committed uptime.

Supports Dietary Supplement cGMP (21 CFR Part 111) documentation with 21 CFR Part 11–friendly e-sign (identity, time, meaning/intent).
Immutable, time-stamped trails; RBAC/least-privilege; retention with restore (no hard deletion).
Status-gated read-only external access with full notification audit.
Regional hosting ensures data stays on the soil of your region; uptime commitments documented.

Time-stamped, immutable audit trails with a clean, side-by-side diff so you can compare any two versions and see who changed what, when, and why.
Complaint/CAPA Dossiers by product/lot/market with AI summary and field-level diffs.
Change Evidence Packs for formulation/label/packaging—impact/risk → approvals → implementation/verification, with dependency proof.
Approval Packets for documents (signatures, redlines, release notes, R&U/Training matrix).