Developing and Implementing an OOS Logic Decision System

With increasing FDA oversight of OOS results, it has become a greater imperative to properly document and manage all the OOS results in the lab. Manual and ad-hoc processes for recording and reporting on OOS events are inefficient, error-prone and can lead to regulatory exposure.

An automated solution for OOS Management enables organizations to establish and follow consistent procedures for managing OOS events. Such solutions should support identification, assessment, investigation and reporting of cases along with the ability to track each incident. In addition to the above, automated solutions should provide reporting and analytics on real-time and historical data.

In this webinar we will discuss:

• The challenges of manual and ad-hoc processes in the OOS environment
• Key aspects for an automated solution including:
  • Recording Events
  • Assessment and Investigation
  • Reviewing and Remediation
  • Reports and Metrics
  • Closed Loop Processes encompassing CAPA & Change control
  • Solution flexibility