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Only about 10 drug products are expected to contain radio frequency identification (RFID) tags on a large scale this year, according to a new study that contends legislative uncertainty and costs are slowing adoption of the anticounterfeit technology.
Although the FDA has shifted away from active Part 11 enforcement, agency officials remain committed to ensuring regulated firms demonstrate their computer software does what it is supposed to do, according to experts.
Drug industry spending on information technology (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.
Configuration management (CM) is an important element in systems validation and should be implemented for each individual system as it is being developed, said Scott Hodges, project manager at Stelex-TVG.
DGR recently interviewed Ajaz Hussain, deputy director of the Office of Pharmaceutical Science (OPS) in the FDA’s Center for Drug Evaluation and Research.
With employee training now playing such a critical role in manufacturing efforts, drugmakers like Novartis have started turning to learning management systems (LMS) to manage the delivery of critical regulatory and corporate policies to their employees.
A pharmaceutical industry task force has recommended that the use of radio-frequency tags for identifying and tracking drug products at the individual item level be at the heart of a system to secure product integrity throughout the supply chain.
As radio-frequency identification (RFID) technology matures and becomes integral to the supply chain, many manufacturing executives are beginning to expect high returns from their investments in RFID systems.