QEdge - Enterprise Quality Management Suite

Product Description

QEdge is an enterprise-wide Risk based, Quality management Software to ensure product Quality and regulatory compliance, and Audit Readiness.

·QEdge eQMS has configured 60 + Process

Data Integrity Part 11 (21 CFR Part 11, Annex 11) compliant Risk Based Validated AI enable QMS Enterprise-wide implementation  GxP audited – MHRA, US FDA, Health Canada, Others

QEdge eQMS has 6 modules: Quality Events, DocControl DocIssuance, Training records, APQR/PQR, and Vendor Qualification.

Quality Event Module is useful for, management of various quality processes such as Change Control, Deviation, CAPA, OOS, OOT, Market complaint, Audit management.

DocControl Module is useful for, management of various document type such as SOP, Specification, STP, WI and its Form / Formats / Annex. 

 DocIssuance Module is useful for, management of controlled copy issuance and its retrieval of various Loose format, BMR copies, Preprinted Logbooks etc. 


Training Record Management Module is useful for, employees training and management of its record 


APQR/PQR Module is a comprehensive Product Quality report of product(s) requires submission to Authorities. 


Vendor Qualification Module is designed to manage vendors and their document verification process From Vendor Registration to Vendor On boding.     

 
Broadly QEdge eQMS is

 
1 QEdge eQMS is operational at more than 30+ Sites including 18+ USFDA approved sites 


2 QEdge eQMS is already inspected and audited by global regulatory agencies including USFDA 


3 QEdge eQMS lowers the risk of any process failures. 


4 QEdge eQMS gives Comprehensive and dynamic reports with trend 


5 QEdge eQMS gives Field level audit trail 


6 QEdge eQMS is a Configurable endpoint solution, where workflows will be configured as per business need.


7 QEdge eQMS is available on Cloud as well to minimize hardware cost.  

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology
Specifications
  • Model
    Quality management, Document management, Document Issuance, Training management, APQR, Vendor Qualification, Audit Management
  • Supplied from
    India

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology

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