Submissions Module

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About the module

  • Manage compliance of all submissions via submission records. Manual submissions are managed in separate workflow, but compliance can be viewed, e.g. across all ICSRs, device reports, PSURs etc.

  • Integrates with AS2 gateway, emails and “burn-links” for secure transmission

  • Auto-detects late submissions and enforces a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations

  • Link to requirements, use requirements to schedule activities and reversely i.e. track the number of actual submissions sent out based on requirements

  • The Submissions overview screen allows for setting search parameters and filter for charting, tables and details for submissions to specific reporting destinations or per destination type e.g. Ethics Committees

  • Integrates with other safety databases Argus Safety, ArisG and Veeva Vault Safety, to allow for automatic creation of submission records in HALOPV.

  • 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.

Further details

HALOPV Submissions module makes it easy and flexible to manage all your submissions in one place. Secure compliance and automate overviews. It is part of the set of Data exchange 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 sales@insife.com - we are looking forward to helping your organization!