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 Features | Feature Name | Feature Description | Available Data | Benefits | ||
|---|---|---|---|---|---|---|
 | List of Standards and Regulations | See all standards and regulation that are applied. See assessment statistics and evidence statistics | Any regulatory data you like | We collect regulatory data to access the biggest markets: Australia, Brasil, Canada, Europe, Japan, USA, and Switzerland. | ||
  | 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 Overview – in real- time | Synchronous overview in a dashboard to show Compliance Status for Project Management and Reporting | auto-generated Statistics and Status over all data | Real-time overview | ||
 | 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 | 70% lower QMS maintenance cost | ||
 | 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 QMS | 70% lower QMS maintenance cost | ||
 | Process Descriptions (SOPs) | Process Descriptions with version controlled content-blocks, release workflow, change history connected to regulatory requirements | SOP templates to various topics | 59% faster QMS process release | ||
  | QMS Global Quality Roles | State your roles, responsibilities, authority and competence requirements at one place. | Sample roles in help | Every employee knows which compliance process is expected. | ||
 | Global Glossary | Version controlled terms to Reduce Redundancy | Sample terms in SOP templates to various topics | no more redundancy | ||
 | Template 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 Matrix | Design 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. | |||
 | Standard Interpretation / GSPRs to Requirements | Define Master Requirements and connect them with all regulatory requirements | any data |