IT Compliance Spotlight on Pharma, Medical Device and Biotech Merger and Acquistions

Mergers and acquisitions are not a new trend in Life Sciences. We have seen pharmaceutical, medical device, and biotech companies growing through mergers and acquisitions for the last two decades. Today, many of these companies are operating with IT-related compliance issues and significant inefficiencies resulting from lack of planning and management fear of political nightmares when trying to consolidate and harmonize methodologies and compliance activities after a merger or an acquisition. Often, management is only concerned with validation activities that are related to hardware and software changes and are not aware of the impact of the integration of new business areas and process changes. We hear executives stating that they’ll consider validation activities once they determine the required changes to computer system architecture and applications. [Read more...]

Cloudy with a Chance of Pharma Security

Cloud computing changes the way companies consume IT resources. It shifts the burden of purchasing and maintaining IT infrastructure to specialized IT providers and allows the users to pay only for the resources they need, when they need them. In this new paradigm, cloud security is a top concern.  Companies want to reap the benefits of cloud computing, but are often hesitant because of concerns about security and compliance. In the 21CFR11 regulation, the FDA focused on requirements for ensuring electronic record integrity, accuracy, and availability for agency review throughout the retention period. [Read more...]

Four Keys to Pharma Mobile Device Management

The “Mobile Transformation” is underway in the world, specifically in the pharmaceutical industry.  Every day, we experience walking around our communities seeing people using their smart phones and tablets.  We have a love affair with our mobile devices, in part because they are so useful.  Workers in pharma companies can use mobile devices for voice, email, and text communications on the go.  In addition, mobile devices give pharma company workers access to the world’s information via the mobile Internet more or less anytime and anywhere.  Mobile applications (apps) are providing functionality for work, as well as for entertainment and personal use.  In the healthcare field, mobile computing is exploding, whether for diagnostic purposes, monitoring various health metrics, imaging, or wellness and health maintenance.
The pharma industry, as with healthcare generally and many other industries, will need to manage business and legal risks arising from the use of mobile devices.
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