Safety reports require balance. Underreport and you may be out of compliance. Overreport and you waste time and resources. Our business accelerator keeps safety reporting in perfect balance.
FMD K&L can assist your pharmacovigilance submissions group in analyzing the current expedited rules configuration of your safety system and provide a fully validated solution.
SafetyTEST is a software solution that surveys your safety system and monitors reports and where they are sent. SafetyTEST contains expedited reporting criteria to deliver daily alerts highlighting instances of underreporting and overreporting.
SafetyTEST improves regulatory compliance without affecting the validation state of your safety system.
- Easier management of expedited rules criteria through an intuitive user interface
- Generation of advanced condition queries for easy modification of existing criteria
- Daily notification of missed reports
- Audit trail functionality
- Compatibility with leading safety systems, including:
- Argus J