Every day we see articles related to Artificial Intelligence and Automation with a wide range of opinions on their safety and utility. Some tout revolutionary process improvements while others fear rogue AI attempting to rewrite critical content and push it out before anyone can review it. In the new world of AI, the underlying fear […]
Validation is the process of ensuring that data, processes, and systems produce accurate and reliable results. It involves verifying that they meet the specified requirements and comply with regulatory standards and industry best practices. Validation is crucial for regulated companies, especially those operating in industries such as pharmaceuticals, medical devices, biotechnology, food and beverage, and […]
Pharmaceutical companies use traditional component content management systems (CCMS) to organize, develop, and manage regulatory documents using a predefined set of rules, templates, and guidelines. While these tools fundamentally contain controlled ways to reuse pre-existing content and to pre-populate key elements, layering on AI tools allows for document automation (where outputs are automatically produced, built […]
In today’s fast-paced business world, efficiency is key. Manual processes and outdated systems can slow down operations, hinder productivity, and lead to costly errors. But what if there was a solution that could revolutionize the way your organization operates? Good news, there is! Introducing Intelex, a leading provider of web-based management software designed to optimize […]
Traditionally, region-specific Health Authorities dictate the format of, and information contained within pharmaceutical labels for any given geography. However, all EU pharmaceutical labels will soon need to be converted from their current health authority-approved format into the ePI FHIR format –and other countries are likely to follow. Vulcan, an HL7 accelerator dedicated to connecting clinical […]
Meeting regulatory requirements and compliance standards is vital for pharmaceutical companies. Not only can non-compliance be catastrophic to patient health and safety, but it can also lead to lawsuits, reputational damage, and significant financial losses for the company. Therefore, pharmaceutical industry executives must possess an intimate understanding of industry-specific regulations and the ability to adhere […]
From hypodermic syringes to insulin pumps to inhalers, the pharmaceutical industry has long employed revolutionary technologies to help deliver safe, reliable drugs to market. Now, in the 21st century, innovative technologies such as artificial intelligence (AI) and machine learning are playing a crucial role in bringing life-saving therapies to market in a faster, more cost-effective way. […]
Each year, Life Sciences companies produce and manage large quantities of regulatory and patient-facing content. To meet compliance standards, ensure patient safety, mitigate risks, and reduce go-to-market cycle times, pharmaceutical companies are continually looking for new technologies and processes to streamline workflows, reduce complexity, and reuse content efficiently. One such technology that has been making waves […]
HL7[1] accelerator Vulcan[2] recently published an implementation guide for FHIR, an interoperability standard intended to facilitate the exchange of healthcare information across the ecosystem. Shortly after, the European Medicines Agency (EMA) announced that it would begin accepting FHIR outputs on a trial basis; other health authorities, including the FDA, are likely to follow suit.[3] The inevitable […]
Product recalls in the life sciences industry are not rare. In Q1 2018 alone, for example, 84 pharmaceutical companies in the U.S. reported at least one recall.[1] While these recalls are often attributed to defective or potentially harmful drugs (such was the case in the infamous 1982 recall of 31 million bottles of Tylenol tainted […]
