PvEdge – Quality Management System
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PvEdge – Quality Management System

Sarjen’s PV Enterprise Quality management system enables implementation of quality processes like Deviations, CAPA, Change controls and Risk assessment for Pharmacovigilance and drug safety departments of CROs and Pharmaceuticals companies.

It is completely configurable and easy to use tool to ensure that the complete track of quality events is digitally tracked with exhaustive audit trails to ensure seamless compliance and record keeping. Makes Organizations always inspection ready.

PV Quality Management System serves two distinct objectives :

Digitization of Quality Processes

PV QMS accommodates Pharmaceutical and CRO industries in a dead set and disciplinary regulatory environment to make QMS more robust and well managed by bringing all the quality processes like investigation, CAPA, deviation, risk assessment, change control and many more on single platform.

This brings in evolution of Lifesciences companies, Regulatory requirements and surprise audits driving organizations to accept automated systems. The PV QMS helps achieve great control for Pharmaceutical companies and CROs to manage their QMSes. It enhances decision making, visibility, and supports readiness for audits better than ever before. Automation eliminates laborious and time-consuming manual document maintenance and tracking.

Compliance of Training Records

The Training records management software module is designed to adopt a systematic approach towards one of the most important parameters for business continuity and organizational growth. It helps in keeping electronic training records in a secure and easily retrievable manner.

The system allows to define key responsibility areas for each employee or a group of employees. And can create training modules and upload training documents and contents. System tracks training requirements and training records for each employee and generate training gaps, as may be the case.

Features and Benefits

  • Easy to implement and use web-based solution
  • Completely configurable and automated workflows
  • Seamless collaboration to bring in efficiencies in workflows
  • Customizable listings to track the progress of each type of process
  • Complete Lifecycle of each record including version control and archival for assured compliance
  • Completely secured and confidentiality maintained using role-based acce