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Software as Medical Device Agile Alignment with GAMP5 Validation - MakroCare

Learn how GAMP 5 validation aligns with agile development processes, reducing risks and ensuring regulatory compliance in medical device software development https://www.makrocare.com/blog/software-as-medical-device-agile-alignment-with-gamp5-validation/

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Software as Medical Device Agile Alignment with GAMP5 Validation - MakroCare

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  1. Software as Medical Device: Agile Alignment with GAMP5 Validation www.makrocare.com

  2. Software as Medical Device: Agile Alignment with GAMP5 Validation The GAMP 5 framework/five-phase approach provides a structured approach to validation that can be applied to agile development processes. This framework is based on a risk-based approach, identifying potential risks and implementing appropriate controls to mitigate those risks. Validation Strategy The validation strategy should outline the validation approach, including the scope, objectives, and should provide a roadmap for validation activities, including testing, documentation, and communication. These documents should be updated throughout the development cycle, reflecting changes in the system’s functionality or regulatory requirements. When performing validations using this Agile strategy, the validation plan must clearly state/include the list of supporting systems used to manage the required validation supporting records/evidences (Agile validation environment/ecosystem). [ Read more…] www.makrocare.com

  3. Thank You www.makrocare.com

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