Zhuhai Drug Control
End-to-End Smart Drug Testing Paradigm
Zhuhai Food & Drug Inspection Institute is a key drug testing institution in the Guangdong-Hong Kong-Macao Greater Bay Area. In 2023, it adopted CNWAYLab PharmaLIMS, assigning a unique electronic ID (QR code/RFID) to each sample. From sample receipt, splitting, testing, review to retention, 8 key nodes are auto-recorded with closed-loop traceability — building an "end-to-end" smart drug testing paradigm.
Challenges & Our Solutions
Before adopting PharmaLIMS, Zhuhai Drug Control faced three core pain points: manual sample handling, long report cycles, and broken traceability chains. The CNWAYLab team, through in-depth research, devised targeted solutions for each — achieving a fundamental shift from "paper-driven" to "data-driven" operations.
Manual Sample Handling
80+ samples daily — registration, splitting, and handover all on paper with no real-time tracking. Inter-department sample transfers relied on phone calls and paper sign-off sheets; during peak periods, samples frequently went "missing."
One-Item-One-Code Full-Chain Traceability
Every sample assigned a unique electronic ID with QR code/RFID dual identification. From receipt, splitting, testing, review to retention — 8 key nodes auto-recorded with timestamps, operators, and status changes. Full-chain traceability at a glance.
Long Report Cycle
Test reports averaged 5 days from data compilation to issuance — analysts manually filled raw data, department heads reviewed item by item, typists transcribed and formatted. Frequent client follow-ups; severe backlog during peak periods, impacting institutional credibility and service efficiency.
Automated Report Engine
Template-driven CoA auto-generation engine: instrument data auto-populates report templates; system auto-matches limits and generates determination conclusions. Supports e-signature and one-click batch issuance. Report cycle reduced from 5 days to 1.5 days, freeing reviewers from extensive repetitive work.
Broken Traceability Chain
Sample retention, re-inspection, and audits required manually searching paper archives — a single sample's full-process records from receipt to report were scattered across filing cabinets in multiple departments. A single audit trace took 30+ minutes, with no guarantee of record completeness or consistency.
Electronic Archive Closed Loop
Full-process electronic archiving from receipt to retention — all operational records, raw data, report versions, and review trails auto-filed into electronic archives. During audits, one-click retrieval by sample ID or time period; complete traceability chain in seconds. The era of searching through cabinets is over.
Core Functional Modules Deployed
PharmaLIMS deployed at Zhuhai Drug Control covers sample management, RFID handover, test scheduling, instrument data, electronic records, report management, retention management, and audit trail — 8 core modules in total.
Sample Registration & Coding
Auto-generates unique electronic ID upon sample receipt; supports QR code and RFID dual-identification printing. One-click sample info registration, auto-numbering — building a digital identity record from the source.
RFID Handover Management
Inter-department sample handover via RFID batch scanning, auto-recording handover time, personnel, and sample list. No need for manual item-by-item counting — handover efficiency improved by 80%+.
Test Task Scheduling
Auto-assigns test tasks based on analyst qualifications, equipment availability, and task priority. Task dashboard shows real-time progress and bottlenecks; department heads stay informed of testing dynamics at all times.
Instrument Data Capture
Connects to mainstream testing instruments including HPLC, GC, ICP-MS, UV-Vis; raw data auto-captured and returned — eliminating manual transcription errors and ensuring data integrity and traceability.
ELN Electronic Records
Structured experiment record templates covering all test items; supports attachment upload, version control, and electronic signatures. Full testing process audit trail replaces paper notebooks.
Report Management CoA
Template-driven auto-generation of test reports, auto-matching standard limits and determination conclusions. Supports multi-level review, e-signature, and batch issuance — full online closed-loop reporting.
Retention Management
Full-process electronic management of retention sample warehousing, inventory, retrieval, and destruction. RFID positioning of retention locations, auto-expiry reminders — ensuring standardized and compliant retention management.
Audit Trail & Archiving
Field-level audit trail auto-records every operation; audit panel supports multi-dimensional search and one-click export. Auto electronic archiving meets drug control institution informatization acceptance and routine regulatory requirements.
Implementation Path & Key Milestones
From process diagnosis to full acceptance — 3 months, progressing steadily through 5 phases, each with clearly defined delivery criteria and acceptance milestones to ensure efficient project delivery.
Weeks 1–2: On-Site Deep Dive, Map Pain Points
CNWAYLab implementation team embedded at Zhuhai Drug Control, visiting and surveying each testing department to map 8 key nodes and identify breakpoints and bottlenecks in existing paper workflows. Designed the one-item-one-code full-chain traceability solution and delivered a detailed blueprint document.
Weeks 3–5: Hardware Installation, Network Setup
Deployed RFID readers, label printers, and mobile scanning terminals. Completed RFID network coverage and signal testing across all departments, ensuring stable and reliable scan handover in the complex lab environment.
Weeks 6–10: System Deployment, Data Integration
PharmaLIMS platform deployed and launched; completed instrument data capture integration, ELN template configuration, report template customization, and permission system setup. Simultaneously conducted module-level functional verification and data interface stress testing.
Weeks 11–12: Old/New Parallel, All-Staff Training
Old and new systems ran in parallel; departments kept paper records as reference alongside online workflows. Organized all-staff operational training and assessment — from sample registration to report issuance, everyone mastered system operations — each role assessed and certified before going live.
Week 13: Formal Go-Live, Assessment Passed
Fully switched to online operations; paper records formally retired from daily business. After go-live, smoothly passed the Guangdong Provincial Drug Administration informatization acceptance review. The one-item-one-code traceability system received high recognition from the acceptance expert panel, marking Zhuhai Drug Control's official entry into a new era of end-to-end smart testing.
"Before, finding a retention sample record meant half an hour digging through filing cabinets. Now, a 3-second scan reveals the complete journey of a sample from receipt to destruction. End-to-end traceability not only boosts efficiency — it truly grounded our quality management system."
Learn How CNWAYLab Can Drive Drug Control Institution Digital Transformation
Whether you are a drug control institute, a food and drug administration, or a third-party pharmaceutical testing organization, we have a matching solution.
Book a one-on-one demo and we will tailor a showcase of how PharmaLIMS addresses the practical challenges that matter most to you.