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Change Control Module

Centralized change request lifecycle management with document attachment, electronic routing, and multi-stage review and approval workflows.

Overview

The Change Control Module by QSI Technologies is a quality compliance software solution designed to provide a convenient and centralized process for managing the change request lifecycle across a group of documents. It is built for life sciences and regulated industries that require structured, auditable workflows for document change management.

The module enables organizations to attach documents to a Change Order and generate an electronic packet when routing those documents through review and signature stages. Users are automatically notified of task activities, and the system supports review, post-implementation steps, and training notifications throughout the lifecycle of a change request.

Key Features

  • Ability to attach reference documents in read-only format to a Change Order
  • Auto-numbering of Change Order packets for consistent identification and traceability
  • Automated notifications sent to users when all training associated with a Change Order has been completed
  • Structured Pre-Review and Formal Review stages to guide documents through the appropriate approval workflow
  • Flexibility to add and remove reviewers and documents during active review stages
  • Group approval functionality allowing all attached documents within a Change Order to be approved collectively

The Change Control Module is part of the broader TMS Quality Compliance Software platform offered by QSI Technologies, supporting organizations in maintaining regulatory compliance through structured, electronic change management processes.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ClinicalManufacturingPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP