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Device and diagnostics companies should integrate compliance standards more effectively into their sales and marketing efforts if they want to meet evolving regulatory requirements and avoid government enforcement actions, experts said at a recent industry conference.
The FDA's steady drumbeat of warning letters and other enforcement activity against medical device manufacturers is due in part to an industry failure to adequately address edata and computer system validation (CSV) compliance, Brooks Software experts said at a recent audioconference.
The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said last week.
Regulatory compliance is a reality and smart FDA-regulated life science companies will leverage those requirements to improve their overall operational efficiency and approach compliance as an opportunity to improve best practices, suggests a white paper from Computer Associates (CA).
In what is viewed as an effort to push industry to more quickly adopt radio-frequency identification (RFID) for anti-counterfeiting, the FDA will "fully implement" regulations related to the Prescription Drug Marketing Act of 1987, requiring drug distributors to provide documentation of the chain of custody for drug products throughout the distribution system, the agency said in a report released June 9 by its Counterfeit Drug Task Force.
iAdvantage Software, a provider of software solutions for managing development and preclinical life science studies, said May 9 it selected Tech Resource Group (TRG), to provide the help desk support for its 21 CFR Part 11-compliant eStudy hosted solution.
Clinical trials sponsors considering a potential clinical site can gauge whether a site has a strong edata compliance programit by how well it documents training and standard operating procedures (SOPs), said an industry expert.
The near-universal use of Microsoft Excel spreadsheets in the pharmaceutical industry constitutes a serious compliance risk for companies that fail to validate them, expert David Harrison warned at a May 3 FDAnews audio conference.
Using esignature technology can help life science companies reduce the costs of conducting clinical trials and improve security while ensuring compliance with 21 CFR Part 11, but selecting the right type of system poses a challenge, according to an expert who hosted a recent webinar.
A growing movement in state legislatures will require pharmaceutical companies to include complete information on gifts their sales representatives make to physicians.