The SAP Digital Manufacturing Cloud (SAP DMC) is SAP’s new MES cloud solution. On the way to the smart or digital factory, SAP DMC sets new standards as a SaaS manufacturing cloud solution and ensures more quality and efficiency in manufacturing. Like all computer-based systems, SAP DMC must be validated and kept valid during operation when used in the highly regulated pharmaceutical industry and medical technology.
Thanks to our many years of experience in the validation of computer-based systems, we know what needs to be taken into account in the individual phases of the system life cycle when deploying GxP-relevant systems in a public cloud deployment model. We focus on the differences and challenges compared to on-premise applications, such as shared responsibility, supplier management, release management.
Based on our experience, we have developed a cost-efficient and scalable software validation methodology over the years. The DHC Best Practice Method is a framework consisting of a process model, work instructions (SOPs), templates, training documents and tools. It covers the entire system lifecycle from initial implementation, through the operational phase, to decommissioning and data archiving.
We have further developed this method for cloud-based systems. We take into account the special characteristics of these systems, such as the user’s reduced control over the system, the management of the service provider or software supplier, the protection of the data in the system and the frequent software changes by the provider.