Give Me a M-E-T-R-I-C-S – Go Quality Metrics!

There has been a raised level of interest in the US recently on the subject of quality metrics as applicable to the pharmaceutical industry. Why? Because the FDA has expressed interest in how metrics could be used by both the industry and regulators to improve quality and better facilitate risk-based regulatory processes.
[Read more...]

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...]