image of Carlos Emilio Rosas

Carlos Emilio Rosas

Global Business Development Manager

Software Solutions Mettler Toledo International

Switzerland

2024 Presentation

21 CFR Part 11 is a set of regulations established by the United States Food and Drug Administration (FDA) that defines how to set up compliant electronic records and signatures in the context of pharmaceutical, biotechnology, and medical device industries.

These regulations require companies to implement measures to ensure electronic records and signatures’ accuracy, reliability, and security, including appropriate technical and procedural controls.

A well-designed laboratory software boosts efficiency and productivity, improves inventory management, and simplifies audit procedures by ensuring process traceability and data security, which are critical to achieving Data Integrity.

Moving away from an old hybrid system of paper and computer programs is a step forward, and implementing a digitalization plan in your lab using laboratory software offers significant benefits.

In this presentation, we are going to visit some major data integrity scandals, present Data Integrity and the most common DI primary issues found by the FDA, and provide seven steps to help avoid data integrity failure.

About the speaker:

Carlos Emilio Rosas is Global Business Development Manager for Software Solutions and LabX Consulting at Mettler Toledo International.

With an industrial engineering education and a keen interest in processes, software, and facilitation; he focuses on solutions for Data Governance, Data Integrity, workflow guidance and efficiencies.

He helps businesses and their laboratories to reach the Paperless Lab goals by integrating benchtop instruments into their lab ecosystem with LabX as part of its Digital Transformation.

He is member of a team providing consulting, seminars, and training on solutions that support Data Integrity within the Production, QC and R&D environment.

He also supports companies where a common solution or standardization over multiple countries and regions is required.