Validation Considerations for Mobile Devices in Regulated Life Sciences Industry

The rapid evolution of the power and diversity of mobile devices has created new challenges for life science company IT departments and their regulators. The vendor driven real-time mobile device software update model has challenged long held IT validation principles based upon user control of configurations.  Larry Isacson, Director of USDM's Customer Relationship Management (CRM) practice, will explore the business impacts, regulatory responses and actions to be taken by life science firms to maintain compliance in the mobile device arena.

The discussion will include:

  • Factors driving the uptake of mobile devices in regulated business processes
  • The challenge mobile devices pose to compliance
  • The reaction of regulatory bodies to the emergence of new mobile platforms
  • How to prevent unintended consequences of mobile device adaption and maintain compliance
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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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