A Collaborative Approach: What GxP Compliance Means for Merck and Dataiku
While GxP has set rules and regulations, each company has their own unique process for GxP vendor/software approval. For Merck, Dataiku needed to complete an extensive questionnaire, respond to Merck’s internal audit team with any follow-up questions, and hold two sessions highlighting the capabilities of Dataiku, the data science platform supporting agility in organizations’ data efforts via collaborative, elastic, and responsible AI. According to Deborah Gilbert, a Senior Account Executive at Dataiku, “It’s a testament to our transparent and well-governed product design. It played a critical role enabling us to get GxP certification for Merck extremely fast.”
While this was Dataiku’s first foray into supporting the process of GxP certification, it was also one of the most efficient audits that the advanced analytics team at Merck has ever performed with a software provider. It will spur new use cases in production environments (on both the regulated and non-regulated portions of their business) and democratize the use of data across different business units at Merck, using Dataiku throughout the supply chain.
Laura Patzer, the product owner for Dataiku at Merck, is the ambassador for getting new users onboarded and is an evangelist internally for Dataiku’s platform. She leads the deployment team and works to mature the Dataiku offering at Merck. When we asked Laura the business value of the GxP certification for Merck using Dataiku, she said, “We’ll now be able to use Dataiku for more use cases, such as those involving manufacturing or patient data.”
At Dataiku, we are working with multiple global pharmaceutical clients to assist them to meet and maintain GxP compliance while using Dataiku in production with medical data and are pleased to have worked together with the team at Merck on this exciting achievement.