In the recent years, Johnson & Johnson (JnJ) has changed and updated their validation approach to fully embrace a digital and risk-based approach to validation. As part of an ongoing project, together with Deloitte, these principles are fully embedded and included during the implementation of a new SAP S/4 HANA platform to further support the business of JnJ. During the presentation we will present JnJ's approach to risk based validation followed by a more in depth look at how these principles are used by Deloitte together with JnJ during the SAP S/4 HANA platform and how this ties back in into the CSA principles as documented in the recent draft guidance from FDA by fully utilizing tools (agile development tools, testing tools, dedicated validation tools) to make the shift from document based validation to record based validation.
Head Europe and Africa Technology Quality & Compliance,
Johnson & Johnson