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4 Takeaways from Recent Regulatory Audit Changes + 3 Benefits of Automating Corrective Actions

May 3, 2017 / by Alexa Sussman

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This week’s roundup brings you updates and insights from the Life Scienceindustry.

First, MPO magazine shows us how the laws for regulatory audits are changing, and how that can impact medical device manufacturers and suppliers in a positive way. Then, ODT Magazine “tests your patience” as it reviews the FDA’s most recent guidance updates to medical device testing.

Finally, the Traqpath blog gives insight into how automating corrective actions benefits your organization.

Happy reading!

Four Takeaways from Recent Regulatory Audit Changes
Author: Alexa Sussman via MPO Magazine

The Life Sciences is a heavily regulated industry, with audits being no exception. Recently, regulatory audit laws have changed which can greatly impact medical device manufacturers and suppliers. Here are 4 key takeaways from the changes:

  1. Harmonized audit programs will ease pain points among regulatory bodies
  2. Lowered costs for both auditors and manufacturers
  3. Reduction in regulatory pressure
  4. Elimination of unnecessary business interruptions

To learn what these changes are and how these takeaways impact organizations, read the full article here.


Testing Your Patience
Author: Mark Crawford via ODT Magazine

The medical device and orthopedic product market is extremely complex, with technological advances and electronics always evolving. Consequently, testing is crucial in making sure products are safe and effective.

This article takes a look at how updated FDA guidance for testing and validating medical devices has impacted manufacturers who are used to their tried-and-true methods.

Read on for more about testing advancements, sterilization and cleanliness, regulatory considerations and more, all from industry experts.


3 Benefits of Automating Corrective Actions in the Life Sciences Indus

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Author: Emily Ysaguirre via the Traqpath Blog

A corrective action system is beyond critical to Life Science companies. This post describes three ways an automated solution for corrective actions helps you meet your goals. With technology on your side, you can:

  • Track all corrective actions
  • Issue corrective actions based on action items
  • Have a centralized location for all corrective actions

Learn how this benefits your organization by reading the post here.

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