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Regulatory & Compliance

CDSCO, WHO-GMP, FDA compliance management

32 Tables
28 Pages
24 APIs

Complete regulatory compliance management for pharmaceutical operations. Manage drug licenses, product registrations, regulatory submissions, and compliance calendars.

Regulatory & Compliance
Workflow

Process Flowchart

Complete step-by-step workflow showing how regulatory & compliance operates

1
▶

License Management

Track all drug manufacturing and sales licenses

2
⚙

Product Registration

Manage product dossiers and registration status

3
⚙

CTD/eCTD Preparation

Build Common Technical Document for submissions

4
⚙

Regulatory Submission

Track submissions to CDSCO, FDA, WHO, etc.

5
◆

Review & Queries

Manage regulatory queries and provide responses

✓ Yes / Pass ✗ No / Fail
6
⚙

Approval Received

Record approval with conditions and validity

7
⚠

Renewal Tracking

Auto-remind for upcoming license/registration renewals

8
✓

Regulatory Audit

Inspection readiness with document preparation

Start Process Decision Alert End
Capabilities

Key Features

Everything you need for regulatory & compliance

📋

Drug License Tracker

All Form 25, 28, 29 licenses with expiry alerts

🏛️

CDSCO Compliance

Track all CDSCO submissions and approvals

🔄

Change Control

Manage change requests with impact assessment

⚡

CAPA Management

Corrective & preventive action tracking

⚠️

Deviation Handling

Record, investigate, and close manufacturing deviations

📄

Document Control

SOPs, policies, master documents with version control

Screens

Application Screens

Key screens available in this module

🔒 app.pharmasofterp.com/compliance-dashboard
PharmaSoft ERP
🔔 C
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
Compliance Dashboard
Regulatory & Compliance / Compliance Dashboard
Export + New
247
Total Records
189
Approved
42
Pending
16
Critical
Monthly Trend
Status Distribution
76%
📊 Compliance Dashboard
🔒 app.pharmasofterp.com/license-tracker
PharmaSoft ERP
🔔 L
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
License Tracker
Regulatory & Compliance / License Tracker
Export + New
🔍 Search license tracker...
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 ›
🔍 License Tracker
🔒 app.pharmasofterp.com/submission-log
PharmaSoft ERP
🔔 S
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
Submission Log
Regulatory & Compliance / Submission Log
Export + New
🔍 Search submission log...
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 ›
📜 Submission Log
🔒 app.pharmasofterp.com/capa-list
PharmaSoft ERP
🔔 C
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
CAPA List
Regulatory & Compliance / CAPA List
Export + New
🔍 Search capa list...
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 ›
📋 CAPA List
🔒 app.pharmasofterp.com/change-control
PharmaSoft ERP
🔔 C
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
Change Control
Regulatory & Compliance / Change Control
Export + New
🔍 Search change control...
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 ›
🔄 Change Control
🔒 app.pharmasofterp.com/document-master
PharmaSoft ERP
🔔 D
📊 Compliance Dashboard
🔍 License Tracker
📜 Submission Log
📋 CAPA List
🔄 Change Control
🗂️ Document Master
Document Master
Regulatory & Compliance / Document Master
Export + New
🔍 Search document master...
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 ›
🗂️ Document Master

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