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How to ensure GxP compliance in Tableau Cloud
Navigating GxP Compliance in the GenAI Analytics Era
It’s clear to say that the advent of AI is reshaping every industry and this has a big impact on how organizations collect, prepare, and govern data and analytics. 3 out of 4 organization leaders express their strong interest in adopting AI in different domains including data and analytics, to improve their competitive advantage. To access these new technologies, even sensitive industries like Financial Services or Healthcare and Life Sciences are preparing to migrate computing systems to the Cloud and effectively benefit from the latest innovations such as GenAI analytics.
This year Tableau Pulse emerged as a pivotal tool for organizations to embrace an AI solution. However, despite the rise in those moving to Tableau Cloud in traditional industries, moving to the Cloud comes with its hurdles and challenges. This is especially heightened when it comes to GxP compliance and HLS companies. This article will explore the challenges delaying HLS companies subject to GxP compliance from moving to Tableau Cloud and how to overcome those challenges.
Are GxP compliance and Tableau Cloud really incompatible?
The HLS industry is highly regulated and these companies must comply with specific regulations, such as GxP. GxP or Good x Practices, encompasses essential quality guidelines and practices, crucial in regulated industries like pharmaceuticals, biotechnology, and food production. By ensuring product safety, efficacy, and quality, GxP compliance protects public health and fosters trust in these sectors.
To be GxP compliant, these companies must be prepared for inspections by health authorities and regulatory bodies with a focus on two areas:
- System validation: validation of dashboards to ensure they constantly meet the required standards and function properly.
- Change management: implement change management practices, such as traceability of changes and their impacts to ultimately maintain the integrity of systems.
HLS companies must be able to demonstrate compliance to regulators by proving complete control over their Tableau Cloud environment and using it as a single source of compliance oversight. However, applying these principles in Tableau Cloud creates challenges due to the following reasons:
Challenge 1: Tableau Server to Tableau Cloud Migration
“How can we qualify and validate the Tableau platform once we’ve migrated?”
Moving to Tableau Cloud is becoming a no-brainer for companies wanting to leverage generative AI but for GxP compliance, this comes with its challenges. The Tableau Cloud platform should be qualified and all dashboards should be validated. Auditors will ask for proof that everything has been qualified and validated after migrating from Tableau Server to Tableau Cloud. They must meticulously document processes for up to the lifetime of a patient, including dashboard test plans and dashboard validation results.
Challenge 2: Tableau Cloud forced upgrades
“The forced upgrades don’t allow us to be GxP compliant, as we have no control over the implementation.”
There is currently a new version of Tableau Cloud every quarter (soon to be every month) , which poses a big obstacle for companies subject to GxP wanting to move to the Cloud. Why? Because HLS companies currently on Tableau Server decide when they want to upgrade; testing timelines can be long (several months) and deployment will only go ahead when they can fully remediate issues, and they will hold a deployment until everything is fully validated. With forced upgrades, this will no longer be possible and GxP compliance doesn’t allow for this.
Challenge 3: Tableau Cloud pre-releases
“How am I supposed to validate the pre-release in 15 days?”
To overcome the problem of these forced upgrades, Tableau will provide a pre-release (or early release, release preview, you name it) to companies subject to GxP 15 days or 1 month before to provide companies the time to validate their environment ahead of the forced upgrade. Despite this pre-release, this still poses a hurdle for organizations because timing is critical for HLS companies; they will need to run the qualification and validation of Tableau and the business dashboards in minimal time to be able to fix potential issues.
Challenge 4: Constant validation and version control
“How can I govern and trace changes in my environment and maintain the integrity of my platform?”
GxP compliance requires organizations to have full traceability of every change in their Tableau environment and be able to prove the integrity of their content. This is challenging for organizations given that it is not provided natively by Tableau.
All these concerns and challenges are critical, especially considering that developing a single successful drug can take 10-15 years and around $2 billion to put out to the public—one error in a dashboard simply cannot happen in the clinical research industry. Being able to overcome these challenges will also allow HLS companies to be more efficient in putting new drugs onto the market due to delivering analytics and insights in a validated state much more effectively.
How can Wiiisdom help ensure GxP compliance?
To overcome these challenges for HLS companies, Wiiisdom provides a path to Tableau Cloud GxP compliance with its Analytics Governance solutions:
Validate and prove the success of your Tableau Cloud migration
Execute automated validation across your platform to ensure GxP compliance when moving to Tableau Cloud. With Wiiisdom’s side-by-side regression testing, validate that the same content that existed in Tableau Server now exists in Tableau Cloud and that there is no change. This includes visual, worksheet data and metadata differences, and functional aspects such as performance. This must be performed throughout the Tableau Cloud migration waves.
Expedite BI Validation
Wiiisdom for Tableau will allow you to easily accelerate content validation for pre-releases to avoid costly errors after they have been officially rolled out. By running regression testing at scale in limited time in Wiiisdom for Tableau, you will have the validation that your Tableau content functions the same as before and after the official release rolls out. This will allow you to maintain data integrity and accuracy.
Schedule and enterprise-scale your BI validation workflows
Easily schedule continuous validation in Wiiisdom for Tableau to ensure a validated Tableau environment around the clock, even during forced upgrades. This will reduce the risk of broken dashboards and reassure stakeholders that their Tableau content remains accurate.
Be notified anytime, anywhere
Complying with GxP requires an organization’s best efforts. Setting up notifications and alerts in your instant messaging application or integrating it with your ticketing system such as Jira or ServiceNow, showcases one’s best efforts because, with them, you become proactive in fixing any issues as quickly as possible.
Get a complete audit trail with version management capabilities
Wiiisdom for Tableau allows you to document every test plan and every pipeline execution result, making all data time-stamped, traceable, archived and readily available to prove to auditors that the Tableau platform is qualified and validated around the clock. Additionally, you can capture unlimited versioning of your Tableau workbooks which are archived as long as is required to ensure full traceability and accountability for GxP compliance purposes.
Discover the new version management capabilities for Tableau:
Overcome GxP compliance challenges with Wiiisdom
Ensuring GxP compliance is one of the main obstacles facing HLS companies when considering moving to Tableau Cloud and accessing innovations such as GenAI analytics because of the lack of control over vendor-led upgrades and human changes to content. Wiiisdom provides Analytics Governance solutions to overcome these challenges and be GxP compliant, helping organizations on their path to achieving ambitious societal benefits while embracing Tableau Cloud.
If you’re working in the HLS industry and want to move to Tableau Cloud, get in contact with us today to discover how to ensure compliance around the clock.
