Risk Management

Out-of-the-box ready. The Dot compliance solution includes a comprehensive risk management solution with the ability to assess risk levels based on severity, probability and ultimately a risk score when handling quality and compliance related events.


Provide a detailed and systematic appraisal of the potential impacts of an amendment, alteration, or event to evaluate their likelihood of impacting processes, safety, quality or other business aspects. Determine risk assessment and potential mitigation across the manufacturing ecosystem.

Determine risk assessment and potential mitigation across the manufacturing ecosystem.

Why Dot?

Best practices pre-configured workflow built-in scoring system

Adjustable parameters to define acceptable risk level

Flexible workflows for different assessment types

Reports and KPIs for measurable insights and data

User-friendly product

"  The product is user friendly. The flows in the system are the best practices that are used in the pharmaceutical industry (21 CFR Part 11, Annex 11, GAMP 5). Almost no adjustments (customizations) are needed. The validation package is very thorough and comprehensive. The software is stable almost without faults."

Computerized Systems Validation in Pharmaceutical 

Bella B.

 Good value for money

"    The overall experience is good, the company uses the system as part of our routine and it has become part of our DNA. we get good support when needed, numerous aspects of the QMS are captured in one system - easiness of use - easy communication with other company employees "

Yoel B.

Avoid lengthy design and configuration processes with our core QMS processes

Dot Compliance is the leading 

ready-to-use Quality Management Software

Start streamlining risk management in a matter of days

A simple, powerful and affordable way to manage your quality processes.