Vendor Control with Partnerships, Not Checklists

More than ever before, pharmaceutical companies leverage the expertise of software, infrastructure, and service providers as an alternative to building equivalent capabilities in-house. Indeed, outsourcing and partnerships with external service organizations, cloud infrastructure providers, and software vendors have become strategic initiatives in most organizations’ plans.
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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.
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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…]