With global regulatory pressure increasing, pharmaceutical companies must prove that their processes are under control and that measures are in place to correct any problem that arises. Simply addressing an excursion in a reactive way is not enough, as production has continued and product is already at risk. There is a need for proactive EM programs to recognize problems before they happen. This has resulted in a shift in thinking toward a Risk-Based approach to monitoring critical manufacturing processes such as aseptic filling of sterile product.
WHERE’S THE RISK?
…IN YOUR DATA.
Risk-Based Environmental Monitoring involves first assessing high risk areas in production and then building a sampling program around them. In order to do this you must first be able to score the level of risk in predetermined areas of production with tools like FMEA (Failure Mode & Effects Analysis). Your data is more than just a number. That’s why traditional EM software needs to go beyond current capabilities and provide the tools necessary to support the risk assessment process.
To Learn More:
- Visit reduce-risk.com to download our latest white paper that highlights the need for automated EM software systems to analyze large amounts of data and recognize risks before a problem occurs.
- Reserve your spot for our upcoming Webinar on Risk-Based EM & Lean Manufacturing in Feb. 2015 by clicking here.