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Pharma manufacturers face a mandate from seven states and the District of Columbia to make sure their IT systems can provide a record of the gifts their sales reps have made to physicians, and the other 43 states are likely to follow within 12 to 18 months, according to a new study by Gartner.
Only 20 percent of pharmaceutical companies are prepared for a July 1 deadline set by the American Medical Association (AMA) to change their IT systems so that doctors can "opt out" of having details of their prescribing behavior made available to sales representatives, according to a study conducted by the Gartner Group.
Pharma companies should not view adherence to the FDA's encouragement of IT adoption as a costly unfunded mandate, but rather as an opportunity to grow the business, according to experts at a recent industry conference.
While known more for its consumer products in other markets, Procter & Gamble (P&G) has some 3,600 employees in its pharmaceutical unit and the company recognizes that smart, proactive risk assessment makes sense on both a regulatory and an operational level, a P&G manager said.
Selecting the right members for your computer system validation (CSV) and 21 CFR Part 11 compliance teams will have a lot to do with whether your efforts are successful, an industry expert said.
The FDA has shifted its regulatory focus from software to whole computer systems — and regulated life sciences companies must adjust for that when developing effective validation programs, former FDA investigator Martin Browning said at a recent FDAnews audioconference.
Life sciences industry spending on IT is rising rapidly and poised to accelerate more than 15 percent each year through 2011, in part due to Part 11 compliance and legacy system remediation projects, says a survey from Frost & Sullivan.
Andrx plans to meet with the FDA on Dec. 14 to discuss manufacturing issues that have stalled the company's drug approvals, Andrx said in a recent filing with the Securities and Exchange Commission (SEC).