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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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