Issue link: https://www.e-digitaleditions.com/i/1462155
18 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Validation duction process should be considered when assessing risk, which drives the assurance/validation plan. Upcoming FDA guidance PharmTech: FDA is planning to draft a guidance on CSA in 2022. What are some of the key aspects of this guidance expected to be? FISCA: As part of the FDA's Case for Quality pro- gram, the FDA encouraged stakeholder participa- tion from the life science manufacturers in identify- ing how to drive higher quality. As part of a 2015 Siemens Digital Industries Medical Device Executive Roundtable event, executive participants identified CSV as a major barrier for realizing value from their technology investments for continuous improvement and innovation. Common paint points included completion length, the amount of necessary docu- mentation, and the multitude of detailed test scripts that need to be generated, among others. Some key aspects we have recommended include: • The promotion of critical thinking when validation planning. • Leveraging of vendor audit results to scale internal validation activities. • Documentation/deliverable rigor based on whether system features have a direct or indi- rect impact on patient safety/product quality. • Unscripted and ad-hoc testing • The promotion of automated test tools. Best practices PharmTech: Can you give an example of risk-based CSA best practices for the life sciences industry? FISCA: The application of CSA enables more time to be spent testing systems vs. generating documenta- tion that serves little value. For example, the use of unscripted test cases and tools enables testing to focus on the detection of software defects. Manufacturers can dynamically test a system using experience and knowledge while adjusting test design based on actual system behavior during test execution. Scripted test cases do not facilitate the use of the testers knowledge of the system and its associated business process be- cause they cannote deviate from prescribed test steps. Unscripted test case does not mean undocumented. The level of documentation retained is proportional to the risk of the feature, function, or operation being tested. For example, even a high-risk item could be tested in an unscripted fashion provided additional effort on planning to ensure coverage and traceability is performed. The activities prior to the start of validation are the basis for determining what additional assurance ac- tivities are needed vs. repeating activities for the sake of documentation for auditors. Organizations should establish a quality system framework that fulfills the requirements and creates records using least burden- some activities. The use of computer system valida- tion tools such as application lifecycle management, bug tracking, and automation should be embraced to reduce this effort. The future of CSA PharmTech: What role do you expect CSA to play in pharma manufacturing as more facilities move to digitalization? FISCA: We are already seeing many pharmaceutical manufacturers embracing CSA and making it an integral part of their CSV process. CSA has already been very impactful in accelerating time to value when implementing software systems for many of these manufacturers. CSA will enable companies to adopt new technologies more quickly, more ef- ficiently, more reliably, and with higher quality. PT