HCCT Group

Herbal QA System — HKCMMS Edition (Source Codes)

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Herbal QA GMP Product Overview

Herbal QA System is an offline, single-executable quality-management platform for herbal and traditional-medicine manufacturers. It runs on a laboratory laptop or a small on-prem server, with no cloud dependency, no subscription, and no per-user telemetry. A single sysadmin creates and administers independent projects — one per plant, brand or contract client — and each project runs its own SQLite database, users, roles, specifications, samples, control charts and audit trail.

v1.3 introduces the HKCMMS Content Pack: a vendor-extracted, 297-monograph reference index of the Hong Kong Chinese Materia Medica Standards, built into the HK Edition executable. Users search by Chinese, Latin or phonetic name, inspect the tests / purity limits / extractives / assay parameters of any monograph, and — with one click — import that monograph as a vendor-draft specification into their project, ready for QA review and approval.

_{Fig. 1 — Project dashboard. Real-time KPIs across samples, OOS, investigations, CAPA, batches and supplier performance.}

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GMP Alignment for International Adoption

Herbal QA System is engineered around the core data-integrity and quality-control principles that underpin GMP frameworks globally, rather than being locked to one jurisdiction’s rulebook. Every action in the system is captured in a full audit trail — old value, new value, user, timestamp, and reason — and approvals are locked in through electronic signatures requiring password re-authentication, giving auditors the traceability that GMP inspections demand.

The system ships with a signed 21 CFR Part 11 / EU GMP Annex 11 conformance statement already executed against a reference installation, plus a full set of empty validation templates (validation plan, user requirements, risk assessment, IQ, OQ, PQ, data-integrity assessment, traceability matrix) that a licensee’s own team can execute for site-specific qualification.

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HKCMMS Content Pack — HKCMMS Database Edition

The HKCMMS Content Pack is the reason to pay the HK Edition premium. It is a bundled, offline SQLite index of 297 monographs from the Hong Kong Chinese Materia Medica Standards (HKCMMS), volumes 1 through 11. For every monograph, the pack surfaces the structured factual skeleton of the CMRO PDF:

• Names — Chinese (Traditional), Latin, phonetic (Pinyin), family, part used, publication year, volume.
• Identification tests — microscopic, physicochemical, TLC, HPLC fingerprint, keyed to the CMRO appendix numbers.
• Purity tests — heavy metals, pesticide residues, aflatoxin mycotoxins, foreign matter, sulphur dioxide, ash, water content, with numeric limits and units.
• Extractives — water-soluble, ethanol-soluble, with method and lower limit.
• Assay — analytes with lower limits, basis (dried substance / anhydrous / as-is).
• Deep links to the official CMRO PDFs (English and Chinese) so the analyst can jump to the source method paragraph, TLC / HPLC gradient tables and chromatograms in one click.

_{Fig. 2 — HKCMMS Content Pack index. 297 monographs · 11 volumes · full-text search on Chinese / Latin / phonetic name}

_{Fig. 3 — Monograph detail (Cortex Moutan). Vendor-draft posture is stated in the yellow banner. Identification, Purity, Extractives and Assay sections show the parsed structured data plus links to the source PDFs.}

1. Search — Chinese, Latin, or phonetic

The pack is indexed with SQLite FTS5. A QA manager who types “ginseng” gets Radix Ginseng, Ginseng Folium and Ginseng Radix et Rhizoma Rubra; a manager who types “當歸” gets Radix Angelicae Sinensis; a manager who types “renshen” gets Radix Ginseng.

_{Fig. 4 — Full-text search across Chinese, Latin and phonetic name fields.}

2. Import as vendor-draft specification

The single button that pays for the HK Edition. On any monograph detail page, “Import as vendor-draft specification” pre-fills a new specification with:

• Every identification test as a specification item with method reference and status “vendor-draft”.
• Every purity test with the parsed numeric limit and unit (“≤ 1.0 %”, “≤ 13 %”, “≤ 5 %”), method reference and status “vendor-draft”.
• Every extractive lower limit and every assay analyte lower limit as a specification item with parsed value and basis.
• Status = draft. Nothing is approved. Every parameter is labelled vendor-draft; QA must review and approve before any batch-release use.

^{Fig. 5 — Import as vendor-draft specification form. QA names the target spec, chooses the raw-material herb, and reviews the generated draft.}

3. Rich content example — Radix Angelicae Sinensis

_{Fig. 6 — Radix Angelicae Sinensis (當歸) monograph detail. Structured names, identification and purity tests, and a full assay panel.}

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Trilingual UI

Every screen — dashboard, navigation, forms, tables, HKCMMS content pack views — is available in English, Traditional Chinese (繁體中文) and Simplified Chinese (简体中文). Language is switched from any page via the header switcher; the choice is persisted in a cookie for 365 days per browser profile.

_{Fig. 7 — Same HKCMMS index in Traditional Chinese. “中藥品質管理系統” · “香港中藥材標準內容包” · full sidebar in 繁體.}

_{Fig. 8 — Same Cortex Moutan detail in Simplified Chinese. “香港中药材标准内容包” · full page localisation.}

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Who Buys This

Head of QA / QA Manager at a TCM Manufacturer

• Runs specifications, sampling, batch release, investigations, CAPA, change control and audit trail — often across multiple product lines and multiple client brands.
• Cannot use SaaS-only QMS platforms because of data-residency requirements, offline factory floors, or client-confidentiality agreements.
• Needs an auditable e-signature trail, provisional-vs-final control limits, and traceability that a client auditor can inspect on the day.
• For HK-based QA managers: needs to demonstrate HKCMMS alignment without maintaining a parallel spreadsheet of the monograph limits.

Founder / operator of a TCM or herbal-supplement brand

• Owns the brand but outsources manufacturing; needs an independent record of specifications, batches, samples, complaints and recalls that is not held solely by the CMDO.
• Wants a system a contract QA consultant can log into as a project admin and hand back — without paying for a seat every month.
• For HK-registered proprietary Chinese medicine brands: needs the HKCMMS parameters loaded into their own specifications, not just referenced in a PDF folder.

Regulatory / QA Consultant serving Multiple Clients

• Manages 3–20 client projects in parallel; each client needs its own isolated project database with its own users and audit trail.
• One workstation install, N independent projects — one sysadmin, N per-project admins.
• Bills the client for spec authoring, methods validation, batch review and investigation reports — this system is the deliverable substrate.

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Deployment & Operations

Install

• Download a single Windows executable (~5 MB Standard, ~6 MB HK Edition).
• Double-click. The system creates its data directory, seeds the system admin, and opens the login page in the default browser.
• No installer, no admin rights on the workstation, no dependency install.

Data

• All data lives in one folder — one system database and one SQLite file per project. Zip the folder to back up. Copy the folder to move.
• No cloud calls. No telemetry. No licence check phones home.
• Each project database is fully independent — different users, different specs, different audit trail.

Users & roles

• One sysadmin creates projects and per-project admins.
• Per project: Admin · QA Manager (approver) · Analyst · Read-only auditor.
• E-signature is captured against the logged-in user; forced password rotation on first login; audit-trail entries carry username, timestamp and reason.

System console — sysadmin

_{Fig. 9 — Login screen with both authentication modes (project user / system administrator).}

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What The System Does

Twenty operational modules organized into six functional groups. Every module is included in both tiers.

1. Dashboard

Every project opens on the same dashboard: samples registered, results recorded, OOS rate, out-of-trend results, open investigations, open CAPA, changes awaiting decision, batches, CAPA ageing, exception trend by month, open CAPA by due date, supplier performance, deadlines within 30 days and parameters with provisional control limits.

_{Fig. 10 — Real project data: 23 samples, 118 results, 0.85% OOS, 2 out-of-trend, 0 open investigations, 2 open CAPA, 1 change awaiting decision, 6 batches.}

2. Specifications & limits

Every specification carries: identification tests, purity tests, extractives, assay analytes, numeric limits, methods, and a status lifecycle (draft → approved → superseded). Approval is an electronic signature captured against a QA-manager user and stamped into the audit trail.

_{Fig. 11— Specifications list. Approved and draft specs, with revision tracking and per-item limits.}

3. Samples, results and control charts

Analysts enter sample results; QA managers approve them; the system automatically feeds the running control charts. Individuals-chart, EWMA and CUSUM are computed on the fly, together with Cp / Cpk / Pp / Ppk process-capability indices, once enough observations are in.

_{Fig. 12 — Samples & results register. Batch, matrix, test, value, unit, verdict, sampler and analyst.}

_{Fig. 13 — SPC chart, upper panel. Individuals control chart with spec limits, computed UCL/LCL/mean, run-rule signal detection, and Cp/Cpk/Pp/Ppk capability panel.}

_{Fig. 14 — SPC chart, lower panel. EWMA (small persistent shifts) and CUSUM (cumulative drift) with the underlying result table below the chart.}

4. Traceability & audit

Every create, update, delete, e-signature, sign-in and sign-out is captured with timestamp, user, old value, new value and reason. Entries cannot be edited or deleted through the application. Exportable to CSV for auditor hand-off.

_{Fig. 15 — Audit trail. Old value → new value with reason, per user, per record, per action. CSV-exportable.}

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Two-tier Product Comparison Table

$19,997.00 – Purchase Checkout Added to cart