PRISYM ID is a leading label lifecycle management solutions provider, with many year's experience implementing compliant solutions for our customers. Here we discuss best practices and interesting industry updates that we've come across.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulatea transformation of labeling infrastructure and approach among global device manufacturers.
Leveraging your supplier is one of the five key principles of the GAMP 5 ‘Risk-based approach to compliant GxP computerised systems’. A guideline document - written for the industry, by the industry – GAMP 5 outlines how organisations can successful achieve project delivery within the life sciences industry.
Ignoring the warning signs of non-compliance is no longer an option Data shows that more than half of all FDA recalls of medical devices since Q1 2014 have been caused by packaging and/or labeling error. One of the most high profile recent examples was the Class I recall of a Peripheral Infusion System, where major mislabeling risked the incorrect use of the product by physicians and raised the potential for serious patient injury or death.
At PRISYM ID we’re keen to understand how medical device, pharmaceutical and clinical trial companies check the labels they print for quality.
Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls. In a recent survey conducted by PRISYM ID, 67% of respondents admitted that human error was the most frequent cause for their labeling errors and 45% frequently experienced quality issues throughout their label production process.
Medical device manufacturers are up against the clock to ensure they are ready by the 24 September 2016 to meet the FDA UDI compliance deadline. Our recent survey found that 33% are not confident or unsure if they are ready for an inspection, while 23% admitted that implementing a label system as the biggest issue.
It’s nearly three years since the original publication of UDI and the industry is well on track to achieving compliance. Indeed, April 2016 saw GUDID Labeler Accounts rise from 240 in October 2014 to 1275* only a year and a half later.
An examination of UDI implementation and lessons for manufacturers of Class II devices In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use. By 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.
As many of you will know, this year PRISYM ID has chosen Thames Hospice as its Charity of the Year. Throughout 2016 we will be raising funds in a variety of innovative and exciting ways all to support the Thames Hospice’s provision of expert nursing, medical and therapeutic care for adults in the local area.