AM14On Tuesday, 14 October, the Key Elements of a Quality System session featured Sun Koo Kim, PhD, Bayer Healthcare and Keith Williams, GXPi who discussed quality systems and Quality by Design (QbD) practices, accessibility and documentation.

Kim asked how many of the attendees were starting a QbD effort and have discovered pitfalls or are skeptical. He introduced three big buckets – What is the goal of risk assessment; why are risk assessments critical to QbD; and what are the first steps in designing QbD?

“The goal of risk assessment is to mitigate risk,” said Kim, who offered a template for each step. “Risk assessment is a blueprint of QbD and as the first step, provides a backbone for what you’ll be doing for the rest of the QbD process.”

Williams offered models for QMS that included “process maps” that reach holistically across the whole enterprise. He offered a discussion on batch record case studies using the process mapping. “Process mapping is critical to finding out what’s going on and for improving QMS,” said Williams.

Later Tuesday afternoon, Robert Kenney and Ethan Smith of Veeva Systems, teamed up for the session, Should all Quality Processes Move to the Cloud?  Kenney’s answer to this question is, yes, that all quality processes should move to the cloud and discussed how cloud technology has developed and how and when pharma quality data should be moved to the cloud.  To explain, he used the federated business model that included globalizing companies and outsourcing as characteristics of the global complexities requiring such a model. “Outsourcing and a mobile workforce have expanded the scope and boundaries of quality processes to partners, such as CROs, labs, distribution and sales,” said Kenney.

Smith added that today more things are going on outside of the organization, and this creates gaps. However, with Pharma as perhaps the most regulated industry, when the auditor comes to the door – who is responsible?

They described an industry cloud as one that is developed to be specifically tailored to fit a particular industry’s needs.  They cited ease of data access, data security, optimized software and hardware, and validation and compliance as some of the requirements for storing pharma quality data as part of an industry cloud system, apart from a cloud system that could be more generalized to only data storage. Agility is a key feature of an industry cloud system, they said, adding that a pharma industry cloud should be developed and operated by people who are experienced in the pharma industry and developed with an end user focus.

“Ideally, an industry cloud provides access, visibility (where processes include metrics) and control,” said Smith, who focused on the validation aspect of a highly customized pharma industry cloud, which can include CAPA processes and life cycle validation.