validation

The silver lining in a labeling system validation effort: four tangible business benefits

Susan Gosnell Life sciences

There’s no way around it. Regulators require that life sciences companies validate their solutions. At the same time, manufacturers are under pressure to streamline operations, reduce costs and increase efficiency to compete in a challenging market environment. In many ways, it might seem like a near-impossible task: spending the time and resources necessary to achieve and maintain compliance, while at …

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), …

labeling trends

2021 – The key trends set to impact the labeling market

Ken Moir Cloud computing

As we look ahead to what 2021 has in store, organizations are increasingly looking for integrated solutions for everything from artwork management to factory labeling and direct marking. As a result, the move to convergence is the trend we expect to change the face of the labeling market. This convergence is supported by the ongoing rollout of centralized label management …

EU MDR

As the EU MDR deadline approaches, seize the opportunity to digitize quality assurance

Susan Gosnell Cloud computing, Life sciences, Medical Devices

The postponement of the EU MDR deadlines has given medical device manufacturers a unique opportunity to digitize quality assurance as they take steps to comply with MDR requirements. By seizing this opportunity, MDMs can simplify the compliance process, ensure greater label accuracy and, ultimately, get their products to market faster. If you’re facing the EU MDR deadline, the last thing …

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, …