QA Stack
QA STACK LIMS

Connect your laboratory
to your manufacturing floor.

Manage samples, enforce testing specifications, and track stability studies in a unified LIMS that talks directly to your quality and production systems.

OOS / OOT Investigations
Out of specification and out of trend exception investigations
ID
Material
Batch
OOS-2026-001
Rosuvastatin Tablets 20mg
BATCH-2826-105

OOS-2026-001

Phase 1: Lab Investigation

Rosuvastatin Tablets 20mg — Assay (Tablet)

Specification
98.0% - 102.0%
Observed Result
92.4%
Batch
BATCH-2826-105
Assigned To
QA Manager
Due Date
OVERDUE — 2026-04-17
Phase 1 — Lab Investigation
Phase 2 — Full Investigation

Phase 1 evaluates possible laboratory causes: calculation errors, reagent issues, instrument malfunction, sample prep errors. Complete all fields before concluding.

e.g. Possible weight error during sample preparation, standard purity not verified...
e.g. 99.2%
e.g. 99.4%

Sample Testing & ELN

End transcription errors.

From the moment a sample is logged and barcoded, its lifecycle is tracked. Analysts use the Electronic Lab Notebook (ELN) to execute testing protocols, pulling data directly from integrated balances and chromatography systems.

  • Direct instrument integration via RS232/TCP.
  • Automated spec comparisons (Pass/Fail).
  • Structured ELN execution templates.
Sample Login
Barcode Generation
Instrument Connect
Test Execution (ELN)
Result Review

OOS/OOT & Batch Disposition

OOS Trigger
Phase 1 Lab Inv.
Phase 2 Mfg Inv.
QA Review
Batch Disposition

Seamless quality handover.

When a result falls Out of Specification, the system automatically locks the batch and initiates a Phase 1 Laboratory Investigation. If escalated to Phase 2, it feeds directly into the QMS for manufacturing review.

  • Automated OOS/OOT flagging.
  • Integrated Phase 1 / Phase 2 workflows.
  • Direct linkage to final batch disposition in eBMR.

Stability Studies & CoA

Automate the long game.

Design stability protocols with complex pull schedules. The system automatically alerts analysts when samples are due, tracks environmental chamber conditions, and automatically compiles the final Certificate of Analysis.

  • Automated stability pull schedules and alerts.
  • Environmental chamber mapping integration.
  • 1-click Certificate of Analysis (CoA) generation.
Protocol Setup
Pull Schedule Alerts
Sample Testing
Trend Analysis
CoA Generation