Importance of Data Integrity in Microbiology Labs
In Partnership With: EPR
Overview
Marie Dorna, director of quality data integrity and digitalization at MSD, discusses the importance of data integrity in microbiology labs, emphasizing the increased focus on this topic due to globalization, economic stressors, and electronic systems. She covers regulations, risk factors, and the Alcoa principle, highlighting the need for a strong foundation, cross-functional teams, and a data integrity strategy. Specific risks in microbiology labs, such as errors in counting and equipment/system risks, are addressed, along with mitigation strategies like education, training, and second person verification. The importance of clear SOP, cross-functional teams, and automation in improving data integrity and efficiency is also emphasized
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Key Learnings:
Data Integrity Essentials:
- Adhering to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) is crucial for ensuring data integrity in microbiology, and maintaining product quality and safety.
Risk Mitigation:
- Address risks from globalization, economic pressures, and electronic systems with robust controls, regular assessments, and comprehensive training. The "fraud triangle" highlights the need for vigilant monitoring and a strong ethical culture.
Best Practices:
- Implement clear SOPs, conduct regular audits, and ensure thorough documentation. Use automated systems and electronic reviews to reduce errors and improve efficiency. Foster an open culture for reporting issues.
Webinar Speaker
Marie Jorna
Director Quality, Data Integrity & Digitalisation Center of Excellence
MSD
Marie Jorna is Quality Director for MSD, Animal Health. Mrs Jorna leads the Data Integrity program for MSD Animal Health Manufaturing division to ensure that GMP data are meeting the ALCOA principles. She is also involved in digitalization projets to standardize and improve processes as well as ensuring Data Integrity. In her previous roles within MSD, she was a Laboratory Manager. Before MSD, she had several roles in other pharmaceutical companies and hospitals in Quality and Risk management. She holds a Master degree from Angers University (France) on Bioproduct Quality Engineering and a Master degree from Lyon University (France) on Management of pharmaceutical and biomedical technology industries. She is currently finishing an Executive Master at Polytechnique school – Innovation and New technology – Polytechnique – Massy, France.