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Pharma LIMS Software — Sample Testing, OOS Investigations & Lab Management

A laboratory information management system built specifically for pharmaceutical QC. Manage sample receiving, in-process testing, OOS investigations, stability studies, and Certificate of Analysis generation — with instrument connectivity and GxP-compliant audit trails. Works standalone or links to your eBMR for complete batch release visibility.

OOS / OOT
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 ID
BATCH-2826-105
Assigned To
QC Lab Lead
Due Date
29-06-2026
✓
Instrument calibration status verified.
✓
Reagent purity & expiry dates confirmed.
✓
Sample preparation dilutions checked.
✓
Chromatography peak integrations reviewed.
99.8%
QC-204 (T. Patil)
Sample LoginTest Results & ELNInstrument ConnectOOS / OOT LogBatch Release SyncStability ManagementCertificate of Analysis

LIMS benefits for QC labs

  • Instrument connectivity: Reduce transcription and speed up result capture.
  • ELN-driven workflows: Standardize protocols and capture raw data auditable for inspections.
  • Stability & CoA automation: Schedule pulls and generate Certificates of Analysis automatically.
Request a LIMS Demo

LIMS Sub-Modules

FDA 21 CFR Part 11 Compliant Laboratory Information Management Workflows

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.

Step 01

Sample Login

QC lab receives samples and generates barcodes with unique identifiers.

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.

Step 01

OOS Result

Laboratory analyst records a test result falling outside specification limits.

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.

Step 01

Protocol Setup

Stability managers design testing protocols with pull intervals.

Laboratory Integration

Sample Chain of Custody & Instrument Parsing

Pharma laboratories require absolute data security. QA Stack LIMS automates sample custody tracking and integrates directly with analytical instruments to eliminate manual transcriptions.

QC Sample Chain of Custody Lifecycle

A fully auditable, step-gated sample lifecycle that tracks custodianship from reception to final release.

Automated Instrument Data Parsing

QA Stack LIMS integrates directly with leading chromatography data systems (CDS) like Waters Empower and Agilent Chromeleon, parsing raw chromatograms securely.

Source (CDS)

Empower / Chromeleon

Analyst completes assay run. System exports raw JSON, CSV, or XML data files containing peak integration parameters.

RUN_ID: HPLC-202606-22
EXPORT_SIZE: 142.6 KB
Target (LIMS Engine)

Secure Ingest & Checksum

Validates file hashes, parses peaks/areas, maps metrics directly to assay specifications, and auto-detects OOS results.

SHA-256 CHECKVALID
Peak Area Ingested Successfully
Data Integrity

ALCOA+ Lab Data Integrity Matrix

ALCOA+ PrincipleLaboratory Data StandardQA Stack LIMS Enforcement Solution
AttributableEvery action must identify the analyst who performed it.
Enforces dual-factor username/password recheck inside ELN steps and logs user IDs to the SQL audit trail.
ContemporaneousData must be recorded at the exact moment of execution.
Saves time-stamps on raw database writes. Gating logic blocks post-dating or pre-dating entries.
OriginalPrimary source raw data must be locked and preserved.
Integrates edge gateways to stream values directly from analytical balances, preventing hand-written transcription steps.
AccurateData must be free from errors and conform to actual assay metrics.
Automated tolerance checking compares peak values and concentrations directly to MBR specifications.
Technical Q&A

Frequently Asked Questions

How does QA Stack integrate with Chromatography Data Systems (CDS) like Empower?+
We configure secure export folders on the Empower server. Upon completion of sample injection runs, Empower writes raw chromatogram summary files (JSON or XML) to the secure gateway. QA Stack LIMS validates the file metadata, verifies the checksum, and maps the peaks, areas, and concentrations directly to sample assay steps.
Can the stability module handle temperature chamber excursions?+
Yes. QA Stack stability module integrates with temperature/humidity mapping probes in validated chambers. If a chamber temperature falls outside parameters for a specified threshold, the LIMS raises a deviation holding the stability samples and alerts the chamber manager.
How is batch disposition synchronized between LIMS and manufacturing?+
LIMS acts as the release gate. When the QC manager signs off on all testing results, the system verifies that all assay specs are "Released." The LIMS then automatically changes the batch status in the connected ERP (e.g. SAP) from "Quality Hold" to "Unrestricted Use," authorizing inventory distribution.
Does LIMS support custom reagent and standards inventory tracking?+
Yes. Reagents, analytical standards, and mobile phase batches are registered in LIMS with unique barcode IDs. During ELN test execution, the system forces analysts to scan the reagent bottle. If a reagent is expired or uncalibrated, the ELN blocks test entry.