Blog

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.

 

[VIDEO] Label Inspection Systems - Can They Really Safeguard Against Product Recalls?

In the medical device industry, label integrity and patient safety are popular mantras – especially when you are dealing with the FDA. Unfortunately, labeling errors during production have contributed to a significant rise in medical device recalls over the past year.

Medical Device Labeling: It’s challenging – We understand your angst! Introducing the 'Labeling Challenges' blog series...

Regardless of the industry that you are in, labeling can be seen as a daunting task with many associated challenges. And that is especially true in the medical device, pharmaceutical and clinical trials industry.

Improving Data Management to Mitigate Risks in Clinical Trial Local Language Labeling

The question of how pharmaceutical R&D and clinical supplies organizations control source data for local languages is currently one of the biggest issues facing clinical trial labeling and packaging. 

Increasing Operational Efficiency: taking a 360° view

Increasing operational efficiency is an aim for all medical device manufacturers and is a driver for change for many organizations. But the question is how without affecting every day operations?

Is ‘Just in Time’ a Just Approach to Driving Efficiencies?

Medical device companies are fully aware of the importance of labeling as part of the production process – but they are also aware of how costly it can be. Traditionally, the industry has relied heavily on using pre-printed labels – for most organizations, it’s “the way it’s always been done.”

Proof positive: is your labeling system fully validated?

The introduction of GAMP guidelines in 1994 for medical device manufacturers should have shone a light on the validation processes that underpin companies’ printing systems. The guidelines indicate that quality cannot be tested by batch but must be built into every stage of the manufacturing process.

Validated label materials

Using the correct label materials in the medical device market is crucial; using the wrong adhesive, label or ribbon can result in non-compliance and labeling errors. To be validated it’s not just about the materials but the combination of those materials that’s important.

Improving Patient Safety with Unique Device Identification

The proposed ruling for Unique Device Identification (UDI) should be welcomed by medical device manufacturers but being compliant by the effective date (based on classification) may be a worry for some organizations.  

Decoding the Methodology Minefield

Methodologies are certainly a minefield of regulations, acronyms and terminology; and that’s even before you get into what it all means, how to implement them or how to manage change.