Quality - QEdge - Enterprise Quality Management Suite

Product Description

Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:

  • Process Control
  • Document Control & Issuance
  • Training Management System
  • Vendor Qualification Management
  • Product Quality Review (PQR) 
  • Audit Management System
  • Trend Analysis
  • New Product Introduction
  • Artwork Management System
  • User Access Management

What makes QEdge different: Configurable & Automated Workflows  |  Process Versioning  |  Automated Intra-Module Dataflow  |  Field & Functional Audit Trails  |  Power BI Dashboards  |  TPA Integration

Compliance:  GxP, FDA 21 CFR Part 11 and Part 820, EudraLex Annex 11, GAMP 5, ISO 9001:2015, GDPR

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
Categories
Specifications
  • Details
    450k+ Training Records Generated | 5000+ SOP’s Implemented | 200k+Quality Processes Executed | 5000+ Vendors Qualified | 40+ Regulatory Audits | 15+ Country Reach | 75+ Implementations
  • Model
    SaaS, Pre-Validated, On-Premises, Cloud Ready, Web-based, Industry Ready
  • Supplied from
    India

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology

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