White Papers

EU MDR Labeling Compliance: Learning The Lessons From UDI

The European medical device industry is in the grip of the biggest changes the market has seen in decades.

Mind Your Language! Requirements for Local Language Labeling in Clinical Trials

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).

A Clear Vision: Developing the right strategy to assure compliant labeling inspection

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.

How the GUDID was it for you?

An examination of UDI implementation and lessons for manufacturers of Class II device

Validation; Business Gain Without the Pain

How leveraging supplier validation capabilities can help transform the validation cycle and drive progress, productivity and profitability.

Delaying Tactics - How a Postponement Strategy can transform documentation processes and bring supply chain agility

Maintaining an efficient supply chain is widely acknowledged as a key strategic imperative for businesses across the global life science sectors.

Aligning For Growth: The Evolution Of Medical Device Labeling

The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector has been a steady evolutionary process – but not everybody has taken the journey.

Time to Act - Has Judgment Day Arrived for Counterfeit Drugs?

An Introduction to The Challenges Presented By Product Codification & Serialization In The Pharmaceutical Sector It is well recognized that the counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. It doesn’t recognize borders or trade agreements and its supply chain is fast to react to new opportunities and, in particular, weaknesses in the legitimate production and supply of medicines and devices. Read our white paper, “Time to Act – Has Judgment Day Arrived for Counterfeit Drugs?” to learn about the differences in approach between the US Electronic Pedigree (ePedigree) based approach and the European style mass serialization approach. DOWNLOAD OUR SERIALIZATION WHITEPAPER

Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This 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.

Label Production Under The Microscope: Can Vision Systems Safeguard Label Integrity?

At its most basic form, the dictionary definition of a label is ‘a piece of paper, card, or other material attached to an object to identify it or give instructions or details concerning its ownership, use, nature, destination, etc.’, however what does this really mean when labeling something of significance such as a product used in the healthcare market?

Getting Ahead Of The Game: Implementing Unique Device Identification Without Derailing Production

For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount.