Validating processe thrugh walkthroughs

One key on Process Safety Management is to conduct a routine process safety audit.Most of the audit is rely on the documentation but it may not be enough to see the improvement on process safety results and sometimes, the result may be surprise when the formal audit is done.More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.Regulatory framework of legacy product Legacy products are believed to be experiencing some kind of “new life” in the pharmaceutical market.Not only must the equipment used to coat devices work consistently, but the medical device manufactured must also be of consistent quality and perform to specification.Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.

The general outline for data validation is listed below.

From an ethical perspective, clinical data affect treatment decisions, which affect patient health, and the patient population in question is virtually all of the United States and a significant fraction of the rest of the world.

For both of these reasons, clinical data quality and integrity are critical.

These walkthroughs use Py Spark and Scala on an Azure Spark cluster to do predictive analytics.

They follow the steps outlined in the Team Data Science Process.