Overview

ValGenesis – Change Management

Risk based, Automated, Configurable, Integrated with Validation Deliverables, and Enterprise-wide Control

Controlling change requests must be managed properly to avoid compliance and business risk . When implemented and managed successfully, an enterprise-wide global change control software can improve efficiency, compliance and reduce business risk.

The ValGenesis Change Management function provides transparency by managing the change control process across all relevant departments from initial request, through pre-approvals, change execution, validation of the changed system, process or document, then implementation and final change control approval. The ValGenesis Change Management module will track all tasks and activities including actions needed to complete the change with the required validation deliverables.

The ValGenesis Change Management solution enforces a standardized and harmonized change control process across the organization while allowing the flexibility to meet specific change types and associated specific processes with defined stakeholders and validation deliverables. This unique approach positions ValGenesis as a comprehensive centralized integrated change management system to manage all types of changes across the organization.

Features

Features and Benefits of ValGenesis CCM – Change Control Management Solution

  • Initiate Change Request – The system allows users to define any type of change request form with any type of fields to capture any type of process. Users can initiate the change request from any part of the organization based on access privileges.
  • Change Review Board (CRB) – The initiated request will go through the CRB for pre-approval. The CRB can make a decision to approve, reject, defer etc. If the change request is accepted by the CRB, the required process map can be selected based on the level or risks, validation requirements and other impacts. The process map will enforce the process requirements and users can not deviate from the defined process.
  • Orchestrate across multiple business groups, entities, plants or countries to effectively manage the change requests.
  • Centralize and streamline change request processing by automatically linking related processes, validation deliverables and information throughout operations for a closed-loop approach
  • Collaborative change management – The system allows multiple stakeholders to effectively collaborate by parallel routing to stakeholder groups.
  • Meet 21 CFR Part 11 and Annex 11 regulatory requirements or closed-loop change control process with time-stamped audit trails and electronic records/signatures.
  • Integrated with Validation – All the impacted validation deliverables will be electronically managed and they will be available for approvers to approve in order to close the change requests.
  • Notices and reminders include hyperlinks to any associated record, report or trend chart
  • Fully configurable with templates for best practices – With its highly configurable change types, workflows and process maps, ValGenesis is the only solution that is comprehensive and flexible enough to manage any type of change across all functional areas. Required best practice templates, workflows and process maps can be added and modifications to existing template workflows can easily be done with a few mouse clicks.
  • Easy integration with other systemsValGenesis Change Management integrates easily with other GxP business systems like ERP, LIMS, DMS, QMS and MES to connect all quality related processes across the organization, so change requests triggered from any source can immediately be captured and managed with validation deliverables.

 

Process

Closed-Loop-Change-Management
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