Medical Device Product Teams are Always Audit-Ready with Matrix.
Автор: Matrix One
Загружено: 2025-03-11
Просмотров: 75
Not being able to show traceability of design control elements during an FDA Audit can result in observations.
If the team relies on manual documentation like google drive or word and excel, traceability is harder to maintain and demonstrate to an auditor.
During development, team members have to manually document every trace
RAQA has to build a roadmap to find things
During the audit, everyone is left scrambling to find what the auditor is asking for
Without a system in place, time and money are wasted, and people are stressed :flushed:!
But there is a better way :slightly_smiling_face:
:film_projector: Watch how this can all be streamlined in the video below.
#FDA #AuditPreparation #Compliance #DesignControls #MedicalDevice #SaMD #MatrixRequirements
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