vaccine labeling

The Critical Role of Labeling in the Vaccine Supply Chain

Susan Gosnell Life sciences, Pharmaceutical

Vaccine supply chains are fast changing, complex and vitally important to society, and nowhere is this more evident than with COVID-19.   While a great deal of attention has been given to streamlining supply chains – and ensuring vaccines reach healthcare providers and their patients around the world – one of the most critical components is also the most overlooked: the …

Medical Device Manufacturers

The Top Four Labeling Challenges Facing Medical Device Manufacturers – And How To Address Them

Susan Gosnell Life sciences, Medical Devices

The medical device market has been growing at a compound annual growth rate of five percent and with an aging population, the COVID-19 pandemic, and the prevalence of chronic disease, it’s showing no signs of slowing. It’s a challenging time for medical device manufacturers. They are forced to balance demands for quality and compliance with operational efficiency – at times …

Prisym ID

Loftware’s Acquisition of PRISYM ID: Uniting the Best Talent in Medical Device and Pharmaceutical Labeling

NiceLabel Team Life sciences, Medical Devices, Pharmaceutical

To find out more about the benefits this recent acquisition provides to customers in the medical device, clinical trials, and pharmaceutical labeling space make sure you register for our upcoming webinar on January 25th at 10AM ET/4PM CET. We’re pleased to today announce that PRISYM ID, a leading provider of regulated content and label management solutions with a focus on …

validation

How Pharmaceutical Manufacturers Can Ease Labeling System Validation

Susan Gosnell Life sciences, Medical Devices, Pharmaceutical

Imagine investing fifteen years or more in developing a promising new drug, only to have a simple labeling error derail your launch plans, or – even worse – result in a product being quarantined or recalled from the market. Unfortunately, this is not at all uncommon. FDA drug recalls are on the rise, increasing 65% over the last decade(Source: GS1), …

Label Cloud Compliance

Easing compliant cloud labeling for regulated companies

Susan Gosnell Cloud computing, Life sciences

Digital transformation has taken the world by storm. An increasing number of companies are adopting cloud-first strategies with pandemic-driven remote work accelerating this transition. However, this step toward modernization comes with some challenges for regulated companies. The myriad of labeling guidelines, along with the requirements and regulations that life sciences companies face can be overwhelming. What’s more, they’re constantly changing …

medical device and labeling and compliance

Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell Life sciences, Medical Devices

The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of …

Take a standardized approach to aggregation

Ken Moir Pharmaceutical

The pharmaceutical industry is one of the most regulated industries in the world. There seems to be no end to the requirements pharmaceutical manufacturers have to comply with, and with good reason. Regulations help ensure the safety and efficacy of medications that millions depend on every day. Relatively new requirements, such as serialization, help to address the growing counterfeit drug …

Talking label best practices for regulated companies

Mari Waldron Life sciences, Pharmaceutical

On September 25, 2019, NiceLabel hosted an event at Medicon Valley Alliance in Copenhagen, Denmark. The day’s theme was best practice in label management: from solution selection and implementation, to integration and process improvement. The presenters shared their knowledge and experience in how to best handle labeling in a regulated environment. Chr. Hansen shares their label transformation journey The first …

validation terms diagram

Validation of increasing importance for life sciences companies

Ken Moir Pharmaceutical

Across life sciences, the practice of label validation has become vital, as both the United States Food and Drug Administration (FDA) and the European Union’s regulators increasingly require electronic validation of pharmaceutical and medical device labeling solutions to maximize safety and security. Due to the heightened focus on validation, pharmaceutical and medical device manufacturers who do not use validated software, …