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  • Home
  • Solutions
    • Quality Processes
      • Change Control
      • Deviation
      • Investigation
      • CAPA Management Software
      • Market Complaint
      • OOS and OOT
      • Pharmacopeial Change Control
    • Document Control
      • SOP
      • Protocol
      • Work Instruction
      • Specification
      • Controlled Copy Release (Doc Issuance)
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    • Ready-to-deploy QMS
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    • Use Case
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  • Contact us

  • Home
  • Solutions
    • Quality Processes
      • Change Control
      • Deviation
      • Investigation
      • CAPA Management Software
      • Market Complaint
      • OOS and OOT
      • Pharmacopeial Change Control
    • Document Control
      • SOP
      • Protocol
      • Work Instruction
      • Specification
      • Controlled Copy Release (Doc Issuance)
    • Learning Management System
    • Product Quality Review (PQR)
    • Vendor Qualification
    • Ready-to-deploy QMS
  • Resources
    • Blogs
    • Case Studies
    • Use Case
  • About us
  • Contact us

Change Control

Effective change management for better control

QEdge Change control management is a step-by-step approach to manage documented, well traceable and compliant approach to changes that take place in a system or product or process in any industry. As rightly said, “Change” is inevitable, and it is important to have robust change management process across the organization for process performance and product quality and, of course, customer safety. It is not limited to any department and must be managed by every department of an organization.

QEdge Change Control

QEdge Change control is a process to manage different change requests in controlled and coordinated manner which provides checks and balances in the quality system by tracking, reviewing and approving the changes.

Sarjen’s EQMS change control management is capable to trigger dependent tasks, such as impact assessment and risk assessment within itself. Impact Analysis and risk Analysis helps to identify the criticality of the proposed change and, using the same analyses QEdge change control helps users in their decision-making process.

QEdge change control system provides effectiveness checks which is totally independent one and can be set monitoring in next upcoming days. It facilitates effectiveness of implemented change, to confirm that the change objectives are achieved and there is no deleterious effect.

Key Benefits of QEdge Process Control

  • It can be integrated with other QMS modules, Document management Software and Training Management Software
  • This integrated system connects the relevant department under one Change control on the centralized information system with automated email notifications, task assignment, and escalation on pending actions to in-house team and suppliers
  • Based on the requirement/criticality, change can be assessed through change committee/change control board
  • Formulation of Action Plan from defined stage/stages
  • Risk assessment tools can be used based on the requirements
  • Separate flow of action plan to avoid process complexity
  • All major process decisions under QA Control for effective monitoring and implementation of change request

QEdge Quality Management Software Suite

  • Quality Processes - QMS
  • Document Management - DMS
  • Training Management - TMS/ LMS
  • Product Review - APQR/ PQR
  • Vendor Qualification
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Phone : +91-79-66214899

Email:  sarjen@sarjen.com

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