SAFETY RISK MANAGEMENT AND PERIODIC REPORTING FROM SAFETY REVIEW BOARD TO LOCAL PHARMACY
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
SIMPLE - SIgnal Management PLaning and Execution
Using simple workflows, manage your global signalling process including the monitoring of progress
Be able to access locally applicable information easily
Act swiftly – be able to make documented decisions quickly which could impact patient safety
Be inspection-ready with reports that demonstrate that the signal detection process is managed and maintained across the organization
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.
A SIMPLE, EASILY TRACEABLE, AND CLEAR PROCESS FOR SIGNAL MANAGEMENT
Signal management is a legislative requirement for pharmaceutical industries to ensure the safety of their products.
Signal detection involves a vast facet of information involving literature searching, the cases currently in the pharmacovigilance (PV) system and is quite specific to the data available to the organization and can lead to swift action relating to the product like recalls and discontinuations.
Organizations continue to evolve the various processes required to maintain their signal detection program – from continuously updating the processes based on health authority initiatives – to changing the submission process for label updates in order to include the step of prior health authority validation of the signal.
Health Authorities request details of the signaling process, including documentation of decisions, which at times can be difficult to obtain quickly as data is stored in complex Excel files, Share-point sites, and other GxP locations.
Knowing the importance of a simple, easily traceable, and clear process, we have invested in making a PV tool that improves the overview and management of signal detection activities. It is called HALO PV