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.

 

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.

The ABCs of IQ, OQ, and PQ

LOL and OMG….today everyone knows what these internet slang terms mean and how to use them. If you are reading this blog you may also be familiar with Medical Device and Life Sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.

What is GMP?

WHAT IS IT? Good Manufacturing Practice (GMP) compliance is part of a quality system covering the manufacture and testing of medical devices, active pharmaceutical ingredients, diagnostics, foods and pharmaceutical products. GMP standards are concerned with both production and quality control.

What is the FDA?

WHAT IS IT? The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment.

HIBC or GS1- Which Way Should We Go?

There’s been an ongoing debate regarding two barcode systems for medical products, HIBC and GTIN from GS1. There’s a school of thought that the industry needs to standardize on one system. But which option is better? And do we really need to pick just one?