LIMS (Laboratory Information Management System)

Data integrity guaranteed by system architecture

ALCOA+ principles are embedded throughout the entire process of creating, modifying, and approving test records. Data integrity is assured simply by performing daily work, without any additional effort.

• Attributable: Author/modifier is automatically recorded on all records. Linked to system user accounts, ensuring "who" did it is always traceable.
• Original: Raw data captured from analytical instruments is preserved in a separate table. Processed results and original data can be cross-referenced at any time.
• Enduring: Electronic Laboratory Notebook (ELN) records are locked after approval and cannot be modified. Unlock events require a reason and leave an audit trail.
• Electronic Signature: PKI (X.509 certificate)-based digital signatures enable legally valid electronic signatures for external submissions. Addresses requirements of 21 CFR Part 11 Sections 11.100/200.
• Audit Trail: Data change history is recorded in JSON format, allowing review of before/after values and change reasons during audits.

OOS investigations performed according to FDA Guidance procedures

When an OOS (Out-of-Specification) result occurs, a 2-phase investigation workflow following FDA OOS Guidance starts automatically.

• Phase I (Laboratory Investigation): Investigates laboratory-level causes such as analyst error, instrument malfunction, or reagent issues. If re-testing is needed, procedures for re-testing with the original sample are provided. If a laboratory cause is confirmed, the investigation concludes at Phase I.
• Phase II (Full-Scale Investigation): When the cause is not laboratory-related, the investigation expands to cover manufacturing processes, raw materials, environmental conditions, and more. Automatically linked to QMS CAPA processes (via EMIT_EVENT-based event integration), continuing through to corrective actions.
• Batch Disposition: Based on investigation results, a 3-level multi-approval procedure (QC → QA → Quality Director) determines one of 5 disposition types: release, reject, destroy, reprocess, or conditional release. The multi-approval procedure required by FDA 21 CFR 211 is reflected. Each approver's decision rationale and timestamp are recorded.

Practical Scenario: A finished product assay test yields a result exceeding USL. The system automatically initiates an OOS investigation workflow. In Phase I, the analyst re-tests the same sample but obtains the same result; instrument calibration status and reagent expiration dates are normal. The investigation escalates to Phase II, where review of the batch's manufacturing records identifies a raw material LOT change as the cause. A QMS CAPA is automatically generated, initiating a corrective action request to the raw material supplier and strengthening incoming inspection criteria. The batch proceeds through QC → QA → Quality Director 3-level approval for a destruction disposition decision.

Direct instrument integration to prevent transcription errors

Interfaces for 8 types of instruments are supported: HPLC, GC, UV-Vis, ICP, AAS, FTIR, XRF, and Karl Fischer. Data output from instruments is automatically transmitted to the system, preventing errors that occur during manual transcription.

• IQ/OQ/PQ verification status is managed per instrument, triggering warnings when tests are performed on unverified instruments
• Calibration cycle management and expiry notification workflows
• Start/end times and anomalies are automatically logged in instrument records

Tracking reagents/reference standards from receipt to use

Reagent receipt, storage, dispensing, and usage history are managed in the system. CAS numbers, SDS, expiration dates, and remaining quantities are visible at a glance, and dispensing records can be logged via touch-based POP screens on the shop floor.

• Reference Standards (CRM/Certified Reference Materials): Certificate information, uncertainty, usage history, and traceability records are maintained to address metrological traceability requirements (ISO 17025 cl.6.5)
• Environmental Monitoring: 5 types of environmental data (temperature, humidity, particulates, microorganisms, differential pressure) are automatically collected from IoT sensors, with alert workflows triggered upon deviations

Automated CoA issuance with streamlined approval process

The flow from test result entry → automatic pass/fail determination → review/approval → automatic CoA (Certificate of Analysis) generation is connected as a single workflow. 4 document templates (CoA, Test Report, Calibration Certificate, CoC) are provided, reducing time spent on form preparation.

• Automatic Pass/Fail Determination: When test results are entered, they are automatically compared against specifications (USL/LSL/Target) for conformance/non-conformance determination. No need for personnel to individually check specifications and make determinations.
• Review/Approval Workflow: Approval proceeds in sequence from analyst → reviewer → approver, with electronic signatures at each stage.
• Proficiency Testing (PT): Z-score and En number-based evaluation objectively verifies laboratory analytical capability. Non-conforming results are linked to corrective actions.
• Measurement Uncertainty: Based on GUM (Guide to the expression of Uncertainty in Measurement), Type A (statistical) / Type B (non-statistical) uncertainties are evaluated, and combined and expanded uncertainties are calculated. Uncertainty can be included in test reports.

Versus Excel/paper-based management

Versus commercial LIMS (SampleManager, LabWare, STARLIMS)

Commercial LIMS products have decades of accumulated depth in sample management (splitting, sequences, worksheets) and instrument integration scope. VEXPLOR LIMS differentiates in the following areas.

There are areas where commercial LIMS have advantages (sample splitting, sequence management, SDMS, barcode labeling, etc.). Suitability varies depending on your laboratory's scale and operational characteristics.

Enhanced regulatory audit readiness

• Data integrity evidence required by FDA, MFDS, and ISO 17025 certification audits can be presented directly from the system.
• OOS investigation procedures and batch disposition decision rationale are systematically recorded, enabling answers to "Why was this decision made?"

Improved test result reliability

• Automatic instrument data capture and raw data preservation reduce the risk of audit findings on test results.
• Reference standard traceability, instrument calibration status, and environmental monitoring data are linked to test results, enabling validation of result validity.

Reduced CoA issuance turnaround time

• Time from test completion to CoA issuance can be reduced. Automatic pass/fail determination and template-based generation decrease manual processing time.

Laboratory operations efficiency

• Real-time visibility into reagent/reference standard inventory and expiration dates prevents use of expired reagents and enables timely ordering.
• Total turnaround time (TAT) from test request to result reporting can be tracked to identify bottlenecks.

From test request to CoA issuance

Test request received → Request review (test method/specification confirmation) → Sample receipt (POP barcode scan)
  → Chain of Custody recording → Sample storage location assignment → Test execution
  → Automatic instrument data capture → Result entry → Automatic pass/fail determination (vs. USL/LSL)
  → [Pass] → Reviewer confirmation → Approver electronic signature → Automatic CoA generation → Issuance
  → [Fail (OOS)] → OOS investigation workflow initiated

OOS investigation flow

OOS occurrence → Phase I (Laboratory Investigation)
  → Analyst error? Instrument malfunction? Reagent issue? → [Cause identified] → Re-test → Phase I concluded
  → [Cause not identified] → Phase II (Full-Scale Investigation)
  → Process/raw material/environmental investigation → Automatic QMS CAPA linkage
  → Batch disposition decision (QC→QA→Quality Director 3-level approval)
  → Release/Reject/Destroy/Reprocess/Conditional Release

Stability testing flow

Stability test plan establishment → Storage condition setup (long-term/accelerated/stress/photostability)
  → Test time point setup (0/1/3/6/9/12/18/24/36 months) → Test alert at each time point
  → Test execution → Result entry → Trend analysis → [Trend deviation] → Investigation/CAPA
  → Final report generation

Instrument management flow

Instrument registration → IQ/OQ/PQ verification → Calibration cycle setup → Scheduled calibration alert
  → Calibration execution → Calibration certificate registration → [Pass] → Available for use
  → [Fail] → Use prohibited → Repair/re-calibration → Re-verification
  → Usage log (start/end/anomalies) automatically recorded