Software: Head in the Cloud
The movement toward cloud-based information storage in medical manufacturing is slow due to regulatory and privacy concerns, but steady.
Understanding “the cloud” is no easy task, because while it is a technological term, it is also a philosophical idea. “The cloud” is a nebulous term that most laypeople use to describe “the place where all our information is stored.” That means photos, music, online documents and perhaps private messages and emails (although we try hard not to think about our private information being stored somewhere that isn’t in our direct control). The cloud often is referred to as one omnipresent entity. There is confusion about how to manage what is sent to this mysterious cloud and how to prevent . . .
Expert Insight:Quality management systems requirements are being
expanded to high-risk mobile devices and now laboratory developed testing
facilities. The FDA is consistently focused on increasing industry’s level of quality
responsibility based on a product’s level of risk/benefit to the patient. Social
media will also impact the medical device industry. Awareness of product issues
spreads quickly via social media, and the medical device industry will need the
ability to monitor, respond to and mitigate the risk of inaccurate information
propagation in the marketplace as well as to regulatory agencies.
– Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions Inc.