Mobile application validation

Mobile application validation

Mobile application validation in GxP‑regulated environments

Mobile applications used in GxP‑regulated environments require thorough Computer System Validation (CSV) to ensure compliance, data integrity, and patient safety. These apps may operate as standalone systems or as components of larger integrated systems, demanding a tailored validation approach.

Key considerations include:

• Understanding how mobile devices store and manage data
• Assessing data connectivity, including interactions with cloud services and back‑end databases
• Addressing platform‑specific risks (iOS vs. Android)
• Managing frequent updates, push notifications, and user access controls
• Performing risk‑based testing based on GAMP® 5 guidelines

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