Life Sciences

Top 8 Pitfalls and Challenges of CAPA Systems and Processes

by | Feb 17, 2020 |

Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies. Every Life Sciences company needs to have an effective CAPA system in place to minimize risk and ensure compliance with regulations, but maintaining an effective CAPA process can be challenging. Challenges can occur at every step of the CAPA process and it requires vigilance to ensure that they don't derail the process and expose the company to unnecessary or excessive risk. Here are the top eight challenges of CAPA systems and processes:...

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BYOD and the Life Sciences Industry: What You Need to Know

by | Feb 15, 2020 | ,

Bringing your own device (BYOD) to work has become commonplace in virtually every field and industry, and life sciences is no exception. For employees, BYOD is enormously freeing – they can use the devices they want when they want them. For IT departments and companies, BYOD can be a nightmare. There are significant security concerns and compliance issues to navigate regarding mobility. Read on to learn how life science firms can balance the benefits of BYOD with the risks and challenges through best practices.   BYOD’s Benefits for Life Science Firms Imagine that clinical trial participants don’t have to travel to the research site for data collection. Instead, their smart watches transmit vital data to researchers, who can gain the information they need for their studies in real...

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Top 7 Benefits of Electronic Batch Records (EBRs)

by | Feb 13, 2020 |

The Life Sciences industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes, many Life Sciences companies still find themselves buried in paper. Implementing Electronic Batch Records (EBRs) within a Life Sciences tailored solution inevitably leads to an increase in productivity. While regulatory reporting and compliance requirements historically drove these organizations to work manually with paper, there have been many advancements in software technology that should be too compelling to ignore. Unfortunately, once manual and paper-based systems are in place, executives tend to stay with...

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Choose Your Own Device and the Life Sciences Industry

by | Jan 8, 2020 | ,

The life sciences industry constantly produces cutting-edge, innovative solutions to help patients live longer, healthier lives. But when it comes to mobile technologies (a cutting-edge field in and of itself), life sciences firms still struggle with the same issues as other companies that aren’t as innovative. Mobile devices present opportunities as well as challenges. Certain mobile technology policies will work better than others. This post discusses the benefits, risks and challenges, and best practices of choose-your-own device (CYOD).   CYOD’s Benefits CYOD aims to give IT departments more control over employee mobile devices than a bring-your-own device (BYOD) policy. Here’s how CYOD works: the company compiles a list of approved mobile devices and supplies them to employees....

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