AIVisionLIMS System User Manual
Complete end-to-end operational manual, ISO/IEC 17025:2017 quality procedures, AI-Vision calibration, and regulatory workflows.
Table of Contents
13 Topics1. System Overview & Compliance Framework
ISO/IEC 17025:2017AIVisionLIMS is an enterprise Laboratory Information Management System engineered for testing, calibration, and environmental testing laboratories operating under international quality standards.
ISO/IEC 17025:2017
Structural Clause 7.1 to 7.8 execution: sampling, handling, testing, validation, QC, reporting, and complaints.
21 CFR Part 11
Complete electronic record integrity, time-stamped immutable audit trails, multi-tier cryptographic sign-offs.
Edge AI-Vision Engine
Automated optical digit reading, chromatogram peak extraction, and human-in-the-loop technical sign-off.
2. Access Control & Role-Based Privileges (RBAC)
Manage RolesAccess to system functions is governed by role-based permissions assigned to laboratory personnel. The platform enforces strict segregation of duties (SoD) to ensure independent review and authorization.
| Role | Assigned Persona | Operational Scope & Responsibilities | Key Authorizations |
|---|---|---|---|
| Administrator | Lab Director / IT Lead | Overall tenant configuration, user provisioning, role permission mapping, and system security. | Full administrative access, user creation, tenant settings. |
| Technical Manager | Head of Testing / Lead Chemist | Approves test methods, manages laboratory equipment calibration, reviews test batch worksheets. | Method validation, equipment maintenance sign-off, worksheet review. |
| Quality Manager | Quality Assurance (QA) Officer | Oversees ISO 17025 quality management system, Westgard QC evaluations, and CAPA resolution. | QC batch review, analytical hold approval, CAPA authorization. |
| Authorized Signatory | NABL Approved Signatory | Executes final technical review and applies cryptographic digital signature seals to Certificates of Analysis. | Final report authorization, ULR allocation, certificate issuance. |
| Senior / Bench Analyst | Testing Chemist / Microbiologist | Executes laboratory worksheets, operates instruments, uploads AI-Vision readouts, and logs raw data. | Sample testing, observation entry, AI-Vision verification. |
| Client / Customer | External Client Organization | Accesses client self-service portal to submit test requisitions, view live testing pipeline, and download reports. | Requisition submission, certificate download, invoice review. |
3. Customer & Client Registry (`/Masters/Customers`)
Open Client RegistryStep-by-Step Procedure: Registering Laboratory Clients
- Navigate to Commercial • Customer Registry from the main navigation menu.
- Click + New Customer to open the registration modal.
- Fill out all mandatory fields:
- Organization Name: Legal commercial name for test certificates and invoices.
- Client Type: Commercial, Government, Healthcare, Academic, or Internal.
- Tax ID / GSTIN: 15-character Indian Goods & Services Tax Identification Number for automated B2B invoicing.
- Payment Terms: Default credit payment period (e.g. 15, 30, 45, or 60 days).
- Registered Address: Formal billing and dispatch address printed on official certificates.
- Click Save Client Profile. The system assigns a unique client code (e.g.
CUST-0001) and enables the self-service portal partition.
4. Sample Accessioning & Chain of Custody (Clause 7.3 & 7.4)
Open Samples ModuleISO/IEC 17025:2017 Clause 7.4 requires that laboratories maintain documented procedures for the transportation, receipt, handling, protection, storage, retention, and disposal of test items.
Automated Barcode Generation
Every registered sample is assigned a standardized Code-128 barcode string:
Chain of Custody (CoC) Protocol
Every custody transfer logs the physical handover of specimens:
- Transferor & Transferee: Digital sign-off of departing and accepting personnel.
- GPS Geolocation: Verified field sampling coordinates (Clause 7.3).
- Integrity Verification: Temperature check (< 4°C for water/food) and container seal integrity.
5. Laboratory Worksheets & Testing (Clause 7.4 & 7.8)
Open WorksheetsWorksheets group analytical test methods assigned to sample batches. Analysts record initial weights, titration volumes, instrument readings, and measurement uncertainty.
Measurement Uncertainty Protocol (ISO 17025 Clause 7.6)
Reported values must include expanded measurement uncertainty calculated with a coverage factor of k = 2.0, providing an approximate 95% confidence interval:
6. AI-Vision Optical Reading Engine (SOP-LAB-005)
Open Vision EngineThe AI-Vision Optical Reading Engine automates instrument readout digitization, eliminating manual transcription errors while maintaining compliance with ISO/IEC 17025 Clause 7.7.
Supported Instrumentation Modalities:
7. Statistical Quality Control (QC) & Levey-Jennings (Clause 7.7.1)
Open QC ModuleISO/IEC 17025 Clause 7.7.1 requires laboratories to monitor their validity of results using Certified Reference Materials (CRMs) plotted against statistical control charts.
Automated Multi-Rule Westgard Engine:
| Westgard Rule | Statistical Condition | Classification | Mandatory Laboratory Action |
|---|---|---|---|
1_2s |
1 control measurement exceeds ±2σ from target mean. | Warning | Caution: Inspect instrument conditions and prepare repeat run. Analytical hold not triggered. |
1_3s |
1 control measurement exceeds ±3σ from target mean. | Rejection | Work halting enforced. Automatic analytical hold placed on test batch. Immediate CAPA required. |
2_2s |
2 consecutive control runs exceed the same ±2σ boundary. | Rejection | Systematic error detected. Analytical run rejected; re-calibration required. |
R_4s |
Difference between two control results in same run exceeds 4σ. | Rejection | Random error detected. Immediate batch hold; re-run control samples. |
4_1s |
4 consecutive control runs exceed +1σ or -1σ on same side. | Rejection | Systematic bias or reagent drift. Re-standardize reagents and recalibrate. |
10_x |
10 consecutive control runs fall on the same side of the target mean. | Rejection | Systematic shift. Investigate standard deterioration and baseline drift. |
8. Proficiency Testing & Inter-Laboratory Comparisons (Clause 7.7.2)
Open PT ModuleProficiency testing evaluates analytical competency by comparing reported results against certified provider values using normalized z-scores:
9. Certificates of Analysis (CoA) & NABL Reporting (Clause 7.8)
Open CertificatesUnder ISO/IEC 17025 Clause 7.8, test results are issued on official Test Certificates incorporating NABL ULR (Unique Lab Report) numbers, cryptographic seals, and public verification QR codes.
NABL ULR Number Format
Automated generation according to NABL-133 requirements:
Tamper-Evident QR Verification
Every certificate computes a SHA-256 cryptographic signature:
10. Invoicing & Commercial Billing (`/Billing`)
Open Billing ModuleAutomated commercial reconciliation connects sample test orders directly to commercial invoicing, Indian GST taxation (CGST + SGST 18% or IGST 18%), and payment receipts.
Billing Lifecycle:
- Invoice Generation: Initiated automatically when a test order transitions to Completed or manually via Billing • Generate Invoice.
- GST Application: Automatically splits between intra-state (9% CGST + 9% SGST) and inter-state (18% IGST) based on the customer's state tax profile.
- Payment Recording: Log receipts with payment method (NEFT, RTGS, UPI, Cheque), reference number, and date.
- Balance Reconciliation: Real-time tracking of partial payments and outstanding accounts receivable.
11. Client Self-Service Portal (`/Portal`)
Open Client PortalThe Client Portal provides laboratory clients with a secure, real-time dashboard into their analytical testing pipeline without contacting lab personnel.
12. 21 CFR Part 11 Audit Trail & QMS CAPA (Clause 8.7)
Open Audit LogsIn compliance with FDA 21 CFR Part 11 and ISO 17025 Clause 8.4, the platform maintains an append-only, tamper-evident audit ledger capturing every operational event.
- Non-Repudiation: Records capture authenticated user identity, exact UTC timestamp, IP address, and entity ID.
- Delta Tracking: Every modification stores JSON snapshots of original and updated values.
- CAPA Automation: Out-of-specification (OOS) results or Westgard 1_3s rejections automatically trigger Clause 8.7 Corrective and Preventive Action incident tickets.
13. Mobile Field App & Offline Synchronization
Flutter Android / iOS
The companion mobile application (nexsoftgen_ailims_mobile) is designed for field sampling teams and bench operators.
Offline SQLite Storage
When collecting environmental samples in remote regions without cellular coverage, sample logs, GPS coordinates, and camera captures are persisted in the local encrypted SQLite database and synchronized upon reconnect.
Field Barcode Scanning & HUD
Analysts scan specimen barcodes directly with the smartphone camera. The live HUD verifies sample temperature, preservation conditions, and allows instant custody transfer sign-offs.