PM-SOP-002 Desarrollo de software

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Navigating GxP standards and the FDA/EMA submission process can be quite challenging. Ensuring safety, quality, and compliance under tight timelines can feel overwhelming at times. In this video, Paweł Przytuła breaks down GxP validation and software best practices, making the process easier to understand. He provides practical insights to help simplify validation and keep your project on track. The presentation is available here: https://go.appsilon.com/what-is-gxp If you're curious about GxP validation, be sure to check out our guide on how the Definition of Done can help streamline your process. Read more: https://go.appsilon.com/gxp-blog 📍 Want to ensure your R and Python code meets FDA and EMA standards? Learn more about the GxP audit here: https://go.appsilon.com/yt-gxp-audit _____________________________ 0:00 Introduction to GxP in Clinical Software Development 0:33 How is GxP Used in the FDA Submission Process? 1:06 Good Programming Practices (GPP) in FDA Submissions 1:50 Good Development Practices (GDP) 2:32 Good Reproducibility Practices (GRP) 3:14 Good Software Validation Practices (GSVP) 4:32 Good Cybersecurity Practices (GCP) 5:01 Good Access Control Practices (GACP) 5:23 Good Documentation Practices (GDP) 5:58 Data Management & Risk Assessment in Software Development 7:11 Need Help with GxP?