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Quality Control & LIMS

Laboratory Information Management with full QC workflow

52 Tables
42 Pages
38 APIs

Complete LIMS system for pharmaceutical testing — from sample login to COA generation. Manage specifications, test methods, stability studies, and OOS/OOT investigations.

Quality Control & LIMS
Workflow

Process Flowchart

Complete step-by-step workflow showing how quality control & lims operates

1

Sample Login

Register incoming samples with unique barcode/QR codes

2

Analyst Assignment

Auto-assign to qualified analysts based on workload & competency

3

Spec & Method Selection

Load applicable specifications and test methods from master

4

Testing & Data Entry

Enter test results with instrument integration support

5

Results vs Specification

Automatic pass/fail comparison against specifications

✓ Yes / Pass ✗ No / Fail
6

OOS Investigation

Trigger OOS workflow if results are Out of Specification

7

Reviewer Approval

Second-person verification and review of test results

8

QA Head Approval

Final quality authority sign-off on batch

✓ Yes / Pass ✗ No / Fail
9

COA Generation

Auto-generate Certificate of Analysis with digital signatures

10

Batch Released

Batch status updated to Released — ready for dispatch

Start Process Decision Alert End
Capabilities

Key Features

Everything you need for quality control & lims

📋

Specification Management

Master specs for RM, PM, intermediates, and finished products

🌡️

Stability Studies

ICH-compliant stability chamber management and trending

⚠️

OOS/OOT Investigation

Structured investigation workflow with CAPA integration

🔧

Instrument Calibration

Track calibration schedules, certificates, and due dates

📄

COA Auto-Generation

One-click Certificate of Analysis with company letterhead

🌿

Environmental Monitoring

Clean room particle counts, temperature, and humidity logs

Screens

Application Screens

Key screens available in this module

🔒 app.pharmasofterp.com/lims-dashboard
PharmaSoft ERP
🔔 L
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
LIMS Dashboard
Quality Control & LIMS / LIMS Dashboard
Export + New
247
Total Records
189
Approved
42
Pending
16
Critical
Monthly Trend
Status Distribution
76%
📊 LIMS Dashboard
🔒 app.pharmasofterp.com/sample-queue
PharmaSoft ERP
🔔 S
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
Sample Queue
Quality Control & LIMS / Sample Queue
Export + New
All Active Pending
# Name / Description Date Status Action
001 Paracetamol IP 500mg 18 Feb 2026 Active
002 Amoxicillin Capsules 17 Feb 2026 Pending
003 Cetrizine HCL 10mg 16 Feb 2026 Active
004 Omeprazole 20mg 15 Feb 2026 In Review
005 Metformin 500mg 14 Feb 2026 Active
Showing 1-5 of 247 records
1 2 3
📋 Sample Queue
🔒 app.pharmasofterp.com/test-entry
PharmaSoft ERP
🔔 T
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
Test Entry
Quality Control & LIMS / Test Entry
Export + New
PH-TES-00142
18 Feb 2026
Paracetamol 500mg ▾
BN-2026-0847
Cancel Save Draft Submit
📝 Test Entry
🔒 app.pharmasofterp.com/stability-matrix
PharmaSoft ERP
🔔 S
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
Stability Matrix
Quality Control & LIMS / Stability Matrix
Export + New
All Active Pending
# Name / Description Date Status Action
001 Paracetamol IP 500mg 18 Feb 2026 Active
002 Amoxicillin Capsules 17 Feb 2026 Pending
003 Cetrizine HCL 10mg 16 Feb 2026 Active
004 Omeprazole 20mg 15 Feb 2026 In Review
005 Metformin 500mg 14 Feb 2026 Active
Showing 1-5 of 247 records
1 2 3
🔢 Stability Matrix
🔒 app.pharmasofterp.com/coa-viewer
PharmaSoft ERP
🔔 C
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
COA Viewer
Quality Control & LIMS / COA Viewer
Export + New
All Active Pending
# Name / Description Date Status Action
001 Paracetamol IP 500mg 18 Feb 2026 Active
002 Amoxicillin Capsules 17 Feb 2026 Pending
003 Cetrizine HCL 10mg 16 Feb 2026 Active
004 Omeprazole 20mg 15 Feb 2026 In Review
005 Metformin 500mg 14 Feb 2026 Active
Showing 1-5 of 247 records
1 2 3
👁️ COA Viewer
🔒 app.pharmasofterp.com/oos-log
PharmaSoft ERP
🔔 O
📊 LIMS Dashboard
📋 Sample Queue
📝 Test Entry
🔢 Stability Matrix
👁️ COA Viewer
📜 OOS Log
OOS Log
Quality Control & LIMS / OOS Log
Export + New
All Active Pending
# Name / Description Date Status Action
001 Paracetamol IP 500mg 18 Feb 2026 Active
002 Amoxicillin Capsules 17 Feb 2026 Pending
003 Cetrizine HCL 10mg 16 Feb 2026 Active
004 Omeprazole 20mg 15 Feb 2026 In Review
005 Metformin 500mg 14 Feb 2026 Active
Showing 1-5 of 247 records
1 2 3
📜 OOS Log

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