Product

Fully integrated regulation software

ColabON’s fully integrated regulation software includes regulatory data. The software traces all regulatory data to your QMS or your product requirements. Traceability and overview help to eliminate duplication and redundancy in your system. As a result, we aim to deliver efficiency and time-to-market gains of 200% and more.

FeatureNow availableCommentAvailable Data

Standard and Regulations

List of Standards and Regulations

Interpretation to requirements
Innovative interpretation logic and synchronous connection to requirementsAny regulatory data you like

Gap Analysis

Gap Analysis:
Process Standards & Regulations Interpretation to QMS
Fully transparent Gap Analysis with advanced interpretation logic. For a synchronous connection between regulatory requirements and QMS. more than 1500 assessed reg. req. integrated. + any data on request
Compliance Overview DashboardSynchronous overview over Compliance Status for Project Management and Reporting
Impact Analysis

Impact Analysis
Fully transparent Impact Analysis to new standard and regulation releases. You get a great basis for your Quality System Planning. Always up to date, always compliant upon request

Process Overview
See all processes, their hierarchy and a figurative process overview in one view. This helps design and understand your system. Employees will find their processes and templates fast.
Process Descriptions (SOPs)Process Descriptions with content-based elements connected to regulatory requirementsProcess Descriptions (SOPs) for QMS.

QMS Global Quality Roles
State your roles, responsibilities, authority and competence requirements at one place.

Global Glossary

Global Glossary
Version controlled global glossary to Reduce Redundancy
QSR Change Control Version controlled content elements (SOP content blocks)

Templates + Template Contents

Template Overview with Roles & Responsibility Matrix
Manage and control redundancy in your current templates and template designerTemplates and

Template contents
QMS: Quality Management System, QSR: Quality System Record

Additional Services

  • Change Management
  • Data Migration
  • Training and Education
  • Consulting
  • Product Standards and their interpretation