New ISPE GAMP® GPG Supports Innovation in Life Sciences Industry
Heather D. WATSON
This week ISPE released The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The first such guidance to discuss critical thinking, agile and IT service management in relation to the life sciences industry, the Guide seeks to apply ISPE GAMP® 5 principles and current good practice to these areas to promote innovation and advancement. This Guide facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, so that companies can introduce innovative approaches to reduce risk to patient safety, product quality, and data integrity.
Guide Co-Leads Heather Watson, Chris Clark, and Sion Wyn discussed the new Guide with ISPE.
Q: In general, what new information can be found in the Guide?
Clark: While ISPE GAMP 5 presents a risk-based approach to ensuring fitness for intended use, some practitioners apply unthinking and rigid table-driven, or tick-in-the box approaches not tailored or proportionate to the needs of different systems. Such suboptimal approaches often waste time and effort on non-value-added activities, leading to insufficient or excessive work with potential budget overspend and delays, and could inhibit innovation and the adoption of new technologies. Furthermore, these approaches may reduce focus on more valuable and essential QA activities.
This GAMP Good Practice Guide provides information to support the adoption of new and improved approaches to software engineering, data management, and “as a Service” offerings (XaaS), including the use of supporting tools, thus facilitating the best use of resources, and encouraging the application of appropriate and proportionate practices.
Q: How will this Guide benefit the life sciences industry?
Watson: This GAMP Good Practice Guide discusses critical thinking, incremental and iterative (Agile) software development models and methods, and IT service management. It shows that by applying existing ISPE GAMP 5 principles and current good practice, it is possible to enable life-science industry innovation and advancement in these areas.
Q: How can critical thinking skills benefit the industry and the patients we serve?
Watson: The application of critical thinking can remove barriers to the introduction of new and innovative technologies. Critical thinking allows the effective interpretation of data and situations while avoiding personal bias, inappropriate assumptions, and other distorting factors to retain rigor and balance.
Overall, the key objective is that computerized systems are fit for their intended use and efficiently maintained in a state of control. The benefits offered by critical thinking come from the experience and knowledge of the Subject Matter Experts (SMEs) specifying, testing, managing, and maintaining computerized systems. The SMEs can identify how best to realize the opportunities offered by critical thinking within a regulated company.
Critical thinking supports the GxP principle of designing in quality (through system design, configuration, and operational controls) rather than the attempted testing in of quality.
Wyn: As part of the Case for Quality program, the US FDA CDRH (Center for Devices and Radiological Health) has identified that an excessive focus on compliance rather than quality may divert resources and management attention toward meeting regulatory compliance requirements rather than adopting best quality practices. This may also deter investment in automation and digital technologies, which could assist in quality improvements and process control. An element of the FDA CDRH Case for Quality program is to promote a risk-based, product-quality and patient-centric approach to Computer Software Assurance (CSA). This encourages critical thinking based on product and process knowledge and QRM.
Q: What is the importance of Agile Software Development?
Clark: Agile Software Development is a set of well-established practices intended to improve the effectiveness of software development, and which have been adopted by many industries. The FDA CDRH Case for Quality program supports the adoption of Agile approaches where appropriate, in order to encourage innovation, eliminate unnecessary costs, and focus on quality and fitness for intended use. This Guide provides practical guidance on the adoption of iterative, incremental, or evolutionary (Agile) approaches to developing GxP computerized systems and how it can be implemented in a way that is completely aligned with GxP and ISPE GAMP 5 principles. Some of the topics covered in the Guide include organizational culture, requirements management, specification and verification, and the use of effective tools and automation.
Q: What can practitioners learn about IT Service Management from this Guide?
Wyn: The chapter on IT Service Management discusses good practices for assessing and managing IT/IS service providers. While regulated companies may use a diverse range of service models from IT/IS service providers to provide IT infrastructure, software, and data services, regulatory accountability always lies with the regulated company.
The regulated company must have defined roles and responsibilities for acceptance and release of GxP computerized systems. When outsourcing or delegating activities, there should be no resultant decrease in product quality, process control, or quality assurance. There should be no increase in the overall risk of the GxP processes. The competence and reliability of service providers must always be ensured.
However, even though regulated companies cannot delegate their regulatory accountabilities to an IT/IS service provider, they may leverage the knowledge, experience, activities, and artifacts of an IT/IS service provider through risk-based assessment, management, and governance processes. A discussion of good practices in these areas is provided.
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