About the module
Maintain overview of observations and signals and track all the decisions and accumulated data over time, version controlled, audit logged and according to GVP Module IX. Separately, manage signal detection schedules and capture the data from the activity.
Pull built-in EVDAS-like reports from ICSR data, or can integrate with 3rd party tools, e.g. Empirica Signal
Auto-generate Signal reports or Signal Management Review reports, format using Word templates. Template based document creation but also with “Snippets that allow controlled introduction of non-core template text
Link to Risks, promote a confirmed signal to a risk/safety concern or setup a routine detection activity from a risk management activity
Link to Requirements Intelligence to ensure that signal notifications are handled timely
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.
Understand, visualize and take action on your product safety data with HALOPV. It is part of the set of Regulatory and Science modules
Want to know more, get a demo or take it for a test drive?
We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail.
Write to firstname.lastname@example.org - we are looking forward to helping your organization!