Biopharma manufacturers who want to validate their cloud-based biomanufacturing systems can’t apply the same processes to the cloud that they apply to their on-premises computer systems. Cloud validation requires something more.
Although applications may be built using validated managed services and hosted by one of the major, validated hyperscalers (like AWS or Azure), the result “is simply a validated infrastructure,” Rajiv Anand, founder and CEO of Quartic.ai, tells GEN.
“In (bio)manufacturing, when it comes to data, you also must account for validation of the edge infrastructure and applications. While you may do a lot of the computing in the cloud, data exchange will invariably engage edge systems, too,” Anand points out.
Therefore, also consider the application programming interfaces (APIs) and how they exchange data, as well as such computer systems validation and GxP validation protocols as installation, operational, and performance qualification.
In selecting a cloud computing environment, Anand recommends exploring “entire systems—just as you do with on-premises systems—that provide the set of data and applications that cover all, or most of, the (bio)manufacturing needs and meet the enterprise cloud standards and policies, (which typically come down to cloud provider, security, and access control).”
Not using a cloud compute environment is becoming less and less of an option. “Hardly any data management software or service providers are investing in technology and resources for on-premises systems,” he explains. “Almost all innovation and technology choices are being built for the cloud.”
Soon, that trend will make it nearly impossible for computing environments outside the cloud to use best-in-class data management and governance applications.
“There are specific needs and uses within biopharma that are very difficult to meet effectively with existing on-premises computing,” Anand elaborates. Collaboration is one of those. As the use of contract development and manufacturing organizations accelerates, internal and external collaborations become more frequent, so the distributed and secure compute, data, and communications infrastructure inherent in cloud computing environments is a natural fit.
Increased agility enabled by the cloud is another driver. As Anand notes, “Legacy, on-premises infrastructure comes with rigid policies of hardware and operating systems,” making it difficult to deploy and connect to new applications. Moving to cloud computing offers almost unlimited flexibility,” so best-of-breed technology can be accessed without concerns regarding the operating system or data exchange protocols.
The need for computer systems validation hasn’t changed since computers first entered the pharmaceutical industry. What has changed is how that validation occurs today, in a cloud computing environment.
