Product Features

See how the magic of ColabON’s compliance tool can help you make the most of your regulatory data – in real time

ColabON’s product features let you trace all regulatory data to evidences. These evidences are content-based and version-controlled. And they sum up in a QMS and product requirements as described in the product feature table.

The benefit of this traceability and systematic content approach is overview, clarity, and information. This is the magic that lets you eliminate of duplications and redundancies. Change becomes manageable. Even a regulation change.

All product features are interconnected, this leads to various benefits.

It’s a SYSTEM! not a pile of documents!

Product FeaturesFeature NameFeature DescriptionAvailable DataBenefits

List of Standards and RegulationsSee all standards and regulation that are applied.

See assessment statistics and evidence statistics
Any regulatory data you likeWe collect regulatory data to access the biggest markets: Australia, Brasil, Canada, Europe, Japan, USA, and Switzerland.
Gap Analysis
Gap List

Gap Analysis

Process Standards & Regulations Interpretation to QMS
Fully transparent Gap Analysis with innovative interpretation logic.

For a synchronous connection between regulatory requirements and QMS.
more than 1500 assessed reg. req. integrated. + any data on request

Including IVDR and MDR
Always up to date, always compliant.

10’000 regulatory requirements can’t be managed in excel.
Compliance OverviewCompliance Overview
in real- time
Synchronous overview in a dashboard to show Compliance Status for Project Management and Reportingauto-generated Statistics and Status over all dataReal-time overview

Impact AnalysisFully 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 70% lower QMS maintenance cost
Process Detail SOP
Process Overview
Process Detail SOP
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.
Use SOP templates and template content proposals of Modular QMS70% lower QMS maintenance cost
Process DetailProcess Descriptions (SOPs)Process Descriptions with version controlled content-blocks, release workflow, change history

connected to regulatory requirements
SOP templates to various topics59% faster QMS process release

QMS Global Quality RolesState your roles, responsibilities, authority and competence requirements at one place. Sample roles in helpEvery employee knows which compliance process is expected.

Global Glossary
Global GlossaryVersion controlled terms to Reduce Redundancy Sample terms in SOP templates to various topicsno more redundancy
Template ContentTemplate Content Version controlled content elements, documented information pieces (SOP content blocks)
More than 200 predefined template contents available as ColabON proposals. So much know-how and examples, ready for you to use.
This is the know-how which makes market access faster and broader.

More time to innovate – Grow your product portfolio by up to 29% with ColabON.

Template Overview with Roles & Responsibility MatrixDesign your templates based on content based template contents.

Manage and control redundancy in your current templates. r

See where all template contents are reported

50% lower maintenance cost for technical documentation

Understand which content of each report.

Product RequirementsStandard Interpretation / GSPRs to RequirementsDefine Master Requirements and connect them with all regulatory requirements any data
QMS: Quality Management System, QSR: Quality System Record