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Change management and version control remain one of the toughest compliance challenges for FDA-regulated life science companies, a fact not lost on industry vendors and customers demanding more flexible tools, says a new study from International Data Corp. (IDC).
Too many FDA-regulated life science companies mistakenly believe that writing and posting a good erecord compliance program is enough, experts stressed at recent events.
A growing movement in state legislatures will require pharmaceutical companies to include complete information on gifts their sales representatives make to physicians.
While drug and device firms know they need to manage their intellectual property electronically, they also face ongoing business and operational challenges around regulatory, quality and project management needs, according to an expert.