If you work in the life sciences industry, you’re likely aware of the advantages that the cloud can bring. With high-performance computing and data science capabilities, the cloud can accelerate clinical research and development, getting new drugs and treatments to the market faster. Whether you’re moving your first workloads to the cloud or adopting a new multicloud strategy, you need to ensure that your cloud provider also supports your regulatory requirements.
Today we’re looking at five key requirements for life sciences companies to consider when choosing a cloud provider. But first, let’s review what GxP means.
GxP is an abbreviation for a set of “good practices” where the x stands for various fields. Examples include good laboratory practices, good distribution practices, good pharmacovigilance practices, and so on. Combine all these good practices and you get GxP, a simple shorthand that encompasses them all.
Whether you work for a biotech company, big Pharma, or a medical device manufacturer, following GxP guidelines helps establish quality standards and controls that strengthen safety and efficiency of government-regulated products. In short, it helps a complex network of related industries be on the same page without the burden of yet another audit and certification.
As more companies move their workloads to the cloud, the same need for common standards applies. Each company can examine all cloud offerings to ensure that they can support GxP regulated workloads.
Many of the requirements and best practices for GxP compliance align with the International Standards Organization’s (ISO) controls. These frameworks help cloud computing providers support customers GxP compliance. While GxP doesn’t have an official certification or accreditation attached to it, understanding how a cloud provider has implemented security, privacy, and quality controls is valuable.
Now that we have some context on GxP, let’s dig in!
GxP guidelines for access management indicate that different uses need different privilege levels. Here, the important principle of least privilege comes into play. When choosing a cloud provider, ensure that they’ve built robust tools that allow for fine-grained access controls. Your role is to assign users to appropriate levels of access within the system. Look for a cloud provider that allows you to manage identities by importing your org chart.
Who made changes? When were they made? What changes were made? Good systems are designed to provide a log of all your data. Your cloud provider can have a strong audit trail solution to serve as evidence for all system use. You ensure its correct implementation.
With an audit trail, tools for change management are critical, such as robust SDLC controls with things like request tracking, security reviews, roll-back plans, and approval processes. Others include ticketing systems, notification plans, roll-back plans, and verifications. Have standard operating procedures implemented in your environment to make the best use of these tools.
Trustworthy and reliable records are essential to ensure the integrity of all GxP systems. A good cloud strategy addresses data integrity and include a record retention policy designed to include data backup, archiving, protection, and destruction procedures. Have a plan to retrieve data for inspection, review, and the ability to copy data when audited. Because you manage your own data, this task primarily belongs to your organization to implement. Don’t forget to regularly test and monitor all systems.
Good practices say that physical and logical security can prevent unauthorized access, damage, loss, or changes to the data. Ideally, a cloud provider has physical safeguards: Guards, gates, pass cards, and tight access control to the physical infrastructure. All security policies and procedures need good documentation and regular review.
As you’re considering your cloud options, examine how each provider interacts with other cloud providers. Multicloud provider strategies are becoming increasingly common and the need for various providers to communicate and interface is critical.
While this consideration isn’t an official GxP standard, it’s a good practice.
We’re deeply committed to making our customers successful in the cloud. If you want more information on how to use Oracle Cloud Infrastructure for GxP workloads, contact one of our representatives.
You can also learn more about how customers are using Oracle Cloud Infrastructure for clinical research, pharmacovigilance solutions and more by visiting the Cloud Infrastructure for Life Sciences page.