ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications PDF

ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications PDF

Name:
ISPE GAMP Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications PDF

Published Date:
10/01/2014

Status:
Active

Description:

Publisher:
International Society for Pharmaceutical Engineering

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
$154.5
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According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. By their very nature mobile devices present a significant challenge to control, and the possibility of putting regulated applications, some of which may be classified as medical devices, into the pockets of the public is new ground for the industry.

This new Good Practice Guide is intended to provide a risk-based approach to implementing and supporting regulated mobile apps, and will be of value to both regulated organizations and mobile app suppliers. It focuses on the unique and specific issues related to mobile apps and provides comprehensive guidance for maintaining compliance and control throughout the lifecycle by applying GAMP principles.
Edition : 1st
File Size : 1 file , 2.5 MB
ISBN(s) : 9781936379750
Note : This product is unavailable in Russia, Belarus
Number of Pages : 96
Published : 10/01/2014

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