Label Cloud Compliance

Easing compliant cloud labeling for regulated companies

Susan Gosnell Cloud computing, Life sciences Leave a Comment

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 Leave a Comment

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 Leave a Comment

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 Leave a Comment

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 1 Comment

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, …