Safety System Diagnostic Review

SSI Strategy has designed and managed complex safety systems as well as other types of business systems.  We understand the need to minimize risk and ensure that the system will function to a high degree of reliability under the best and most challenging of circumstances. Our Safety System Diagnostic is a business review of the entire safety system or specific components.  During our review we will place special attention on analyzing such high risk areas as interfaces between groups or parts of the organization.

Our proprietary 6-T ModelTM methodology for safety system review and design allows us to very quickly analyze such key components as:

  • Safety information intake, locally and globally
  • Safety information processing either centrally or at multiple locations
  • Distribution of information to health authorities
  • Safety Signal Detection and Analysis
  • Disposition of safety signals and safety governance
  • The Quality Management System overseeing the system
  • Safety document preparation and submission process
  • Inspection readiness
  • Business continuity planning
  • Pharmacovigilance Training System

We must emphasize that this is NOT AUDITING. [nbspUnlike auditing, our strategy consultants take a highly pragmatic approach toward a system review.  We perform a business review designed to ensure that any gaps or failure points, are identified.  SSI Strategy will provide a summary as well as actionable recommendations to remediate any identified risk areas.  We have relationships with several high quality auditors that can be engaged if necessary.

Following the analysis, Our extensive PV experience allows us to work with your team to implement fixes and solutions in a manner that is consistent with your corporate philosophy and resourcing.