Global clinical trials labeling can be a complex subject and is an integral part of clinical trials supplies management. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels - including booklets and instructions for use (IFUs).
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.
An examination of UDI implementation and lessons for manufacturers of Class II device
How leveraging supplier label lifecycle capabilities can help transform the validation cycle and drive progress, productivity and profitability.
Global clinical trials labeling is a complex subject and an integral part of clinical trials supplies management. Much varies in terms of the systems and processes employed in designing, populating and printing labels (including booklets and IFUs).
Delaying Tactics - How a Postponement Strategy can transform documentation processes and bring supply chain agility
The era of the Postponement Strategy, also known as ‘delayed differentiation’, is slowly emerging in the life science sectors. Moreover, it is moving beyond the Just in Time delivery of product labels, and being applied to the more agile – and efficient – production of ancillary documentation right across the packaging and labeling lifecycle. An age-old proverb suggests that ‘good things come to those who wait’.
Over the past 20 years, developing labeling solutions for the highly regulated devices sector has been a steady, evolutionary process, but not everyone has completed the journey. The introduction of a common UDI mandate is a once in a lifetime game-changer that gives medical device companies no choice but to adapt to this standard.
Counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety, and affects all of us. The pharmaceutical industry has developed a variety of covert and overt anti-counterfeit strategies, ranging from sophisticated design and labeling to deploying field agents to investigate potential counterfeit instances. However, these measures alone are not sufficient.
Since March of 1997, FDA 21 CFR Part 11 has allowed Medical Device and Life Science organizations to use electronic records and signatures instead of paper. This monumental move helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.
In a recent vision systems survey of PRISYM ID customers, 67% of respondents indicated that the most frequent cause of errors during the label printing process was due to human error – a statistic that just can’t be ignored. Due to the high incidence of errors, vision systems have recently become an important element of the label inspection process delivering speed, consistency and accuracy.
Due to increasing interest in public safety and protection of public health, the FDA has adopted a rule for Unique Device Identification (UDI). This rule was designed to enhance safety by identifying labeling errors involving medical devices and providing rapid resolution of device problems.