Quality Processes

Catalyze quality with effectiveness

Qedge, developed by Sarjen system, is web based fully dynamic and electronic quality process control, having experience of development of software solution since 1998 and development of regulatory solutions since 2006, what Sarjen’s belief is all round CORE QUALITY & not just a visual delight!

QEdge accommodates pharmaceutical and biotech industries in a dead set and disciplinary regulatory environment to make QMS more robust and well managed by bringing all the quality documents like market complaints, investigation, CAPA, deviation, risk assessment, change control and many more on single platform.

Swift evolution of Lifesciences companies, regulatory requirements and surprise audits are driving Organizations to adopt automated systems. Qedge EQMS helps Pharmaceutical and Biotech companies to manage their QMS process with poise. It enhances decision making, visibility, and supports readiness for audits better than ever before. Manual document maintenance and tracking turns to be laborious and consumes time on repetitive efforts.

QEdge quality process control has the functionality that after adaptation of the software by companies, it allows them to configure the software and use on current business policies and quality processes.

Key Benefits of quality process control

  • 21 CFR part 11 and EU GMP Annex 11 compliant software with field level audit trail
  • Fully compliant with regulatory guidelines
  • Web based system can be accessed across sites without individual installations
  • Improves efficiency and reduce operational costs of managing implementation activity
  • Assured timely approvals & closures with the help of system generated notifications and reminders along with effective handling of escalations
  • Inter departments and Intra department transparency at operational level is greatly improved
  • Smart search feature
  • Emails notification for each process/stage record
  • User defined listing reports for each process
  • Scheduled Auto e-mails of process listings to specified users
  • Overall status dashboard for each process
  • Real status of each record on one go
  • Role and scope-based system
  • Customize workflow with business and validation rule
  • Auto routing workflow to assigned profile
  • Identify workflow status with unique color legends

Electronic signature and electronic records lead to better regulatory compliance in comparison to manual approach.

The reporting capabilities helps to trace information based on individual fields values for audit purpose. Scheduled reports can be sent through e-mail to top representatives across the organization.

Contact us for QEdge electronic quality process control