GxP Lifeline Newsletter
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September | 2017
MasterControl GxP Lifeline
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Coping with Scoping a CSV/Part 11 Audit
by Laurie Meehan, Social Media Manager; Polaris Compliance Consultants

 

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy.

 

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Add Cybersecurity Education to Every Employee’s Job Description
by David Jensen, Staff Writer, MasterControl

 

The recent surge of security breaches and ransomware attacks is reinforcing the need to make cybersecurity an all-hands endeavor. Despite all the cybersecurity tools that companies are implementing, security breaches are still rampant because one of the top cybersecurity weaknesses in all industries is the lack of training employees on cybersecurity.

 

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Ten Most Common Reasons for FDA 483s in Pharmaceutical Environments
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Demo Introduction: MasterControl Clinical eTMF Management System
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SPECIAL PHARMA FEATURE
Cord cutters are dropping TV in record numbers. Should pharma ad buyers panic?
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SPECIAL BLOOD & TISSUE FEATURE
Is Idarucizumab the First “Antidote” to a Direct Oral Anticoagulant?
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Supply Chain Risk Management: An Ever-Changing Mosaic
by David R. Butcher, Staff Writer, MasterControl

 

We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability. Developing risk management strategies and embedding resilience processes can enhance the organization’s ability to actively assess and manage risk.

 

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Good Communication Skills are Key for Inspection Readiness
by James Jardine, MasterControl Staff Writer

 

When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you willgather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.

 

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