In this era of digital transformation, where artificial intelligence, virtual and augmented reality have garnered attention, cloud computing is proving to be the enabler for these technologies. Pharmaceutical, medical devices and biotech companies are increasingly exploring digital solutions to improve their drug development processes, supply chain, research, manufacturing of medicines and devices etc. Cloud infrastructure is based on a shared responsibility model, which eases the technical responsibilities of an organisation. The cost-effective pay-as-you-go solutions, computing scalability, advanced analytics and automation capability provided by cloud give an edge over on-premises infrastructure. This can significantly improve and optimize various activities such as collaborative research and real-time data analysis across the pharma value chain and accelerate profitability. Along with cloud, colocation data centers are also garnering interest since the providers permit customers to use their own hardware and configuration that meets their evolving requirements. While these services have enamored other industries, for life sciences industry, the uptake has been a little slower in comparison. The life sciences industry has high-standard and stringent regulations. Technology systems using GxP processes — such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Distribution Practices (GDP) — require validation or adherence to a set of regulations or guidelines for organizations across the value chain. Data integrity, privacy, data protection, vulnerability, and compliance are key risks that must be mitigated and managed when moving to cloud. Traditional validation practices with agile methodology required creating and deploying codes in small packages that are created on development, tested on quality and deployed on production. The need today is to build a validation framework for continuous code built, testing and deployment using automation tools and techniques. Regular monitoring of the release and infrastructure management based on the changing requirement is an essential part. Onboarding the cloud infrastructure requires a clear approach to ensure that all risks are considered, mitigation controls are implemented and required evidence is documented for a smooth and compliant movement to the cloud landscape. This paper explores a phased approach to implement GxP compliance in cloud IT infrastructure and colocation facilities. Areas that require attention and need due diligence, to meet the regulatory requirements have been highlighted. Moving to cloud requires active planning and defining a clear strategy to ensure compliance. Onboarding the right implementation partner with skillset in both technical and regulatory aspect of cloud services is essential for a compliant transition. Cloud is being gradually adopted to help introduce innovation in research methods, enable clinical collaborations, and enter new markets. Technology is playing a vital role in enhancing organization’s computing and analytical capacity, thus removing bottlenecks associated with supply chain, research, production, marketing, and sales.
If the path to cloud adoption in not a well thought out strategy and technology partners are not aligned with the company’s objective, it can lead to serious performance and compliance issues. However, if the opportunities and threats associated with cloud migration are well mapped and defined, it could lead to opening new avenues for implementing strategic and innovative solutions.
