GAMP® 5: Insights from the Update to the 2nd Edition

The principles described in the 2nd edition of GAMP® 5 provide advanced guidelines for achieving GxP-compliant automated systems that are fit for their intended use and meet regulatory requirements. By correctly applying the knowledge from the GAMP guide, you ensure that compliance is achieved in a way that adds value to your business. This is done by focusing on aspects that are critical to patient safety, product quality, and data integrity.

The approach is not only aimed at achieving compliance but also at maintaining it throughout the system’s lifecycle. One of the updates concerns how to scale or define the validation approach: It must be ensured that this is based on a thorough understanding of the business process and the system or product. To do this effectively, historical data and supplier knowledge must not be overlooked. The validation effort must be proportionate to the level of risk, the scope and complexity of the system, the novelty, and the outcome of the supplier assessment, with an emphasis on the elements that most significantly impact patient safety, product quality, and data integrity.

Although the first edition already stated that the validation approach must be scaled and justified, the second edition gives this the attention it deserves through the concept of critical thinking, as this is what defines sound and intelligent validation. Critical thinking must be applied so that decisions are made in a well-informed and rational manner at crucial moments within the system’s lifecycle. This certainly does not mean that all systems must be treated the same way, nor that the same lifecycle activities must be applied to a system when it is used in different organizations or for different intended applications.

Software development has evolved over the years. Large projects are increasingly carried out in a non-linear manner, as this is the best approach for discovery, learning, and continuous improvement. The 2nd edition describes how specification and verification can be efficiently addressed when using more iterative and incremental methods, such as Agile software development for applications intended for use in a GxP environment. Nevertheless, the linear approach remains suitable for projects in which requirements are fully identified and defined from the outset (for example, smaller software development projects or the procurement of COTS products).

Due to the increasing use of cloud services (IaaS, PaaS, and SaaS)—that is, the outsourcing of infrastructure, the software platform, or the software application—the importance of service providers has grown, a topic addressed in the update. The use of supplier knowledge, experience, and documentation must, where possible, be done in a justified manner.

The approach to software development and validation must be adapted to the assessment of the supplier and the amount of usable results. In addition to the increasingly iterative and incremental nature of software development, the use of software tools and automation has also increased, as their use can facilitate greater control and lower risk levels throughout the lifecycle, thereby delivering a higher-quality product. Tools and systems can be used at various stages, namely during implementation (specifying requirements, conducting risk assessments, etc.), testing, and maintenance of automated systems. The focus should be on testing that adds value, while cumbersome documentation should be avoided.

Various types of testing can be used to optimally verify the system for its intended use. By using systems, it is also no longer necessary to record all information about the system in a traditional paper-based manner; instead, information can be recorded in systems and tools as appropriate, which increases efficiency and reduces the manual workload during the various lifecycle phases while ensuring improved traceability, searchability, and data security. To overcome the inherent reluctance of GxP sectors to implement new emerging technologies without guidance, the 2nd edition specifically addresses several new technologies that can offer new benefits if embraced. Guidance and examples are provided on the use of blockchain, artificial intelligence, and machine learning within GxP applications. Another part of the update concerns improved alignment with the IT Infrastructure Library (ITIL), which provides IT guidelines for best practices in managing IT services and improving IT support and service levels.

Looking for validation services?

FC&P offers validation services that comply with the latest regulations and guidelines, such as GAMP 2nd Edition regarding the validation of automated systems. For assistance in defining validation approaches, implementing identified lifecycle outcomes, and other validation and quality services, please contact us.