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21 CFR Part 11 Compliance: What You Need to Know

by Merit Solutions | Feb 20, 2020 | Life Sciences

In 1997, the FDA enacted regulation 21 CFR Part 11, which outlines how FDA regulated industries must handle electronic signatures and electronic records. This regulation sets the standards that must be met by pharmaceutical, medical device, and bio-tech companies that...

Top 8 Pitfalls and Challenges of CAPA Systems and Processes

by Merit Solutions | Feb 17, 2020 | Life Sciences

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...

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

by Merit Solutions | Feb 15, 2020 | Enterprise Mobility, Life Sciences

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...

Top 7 Benefits of Electronic Batch Records (EBRs)

by Merit Solutions | Feb 13, 2020 | Life Sciences

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...

Choose Your Own Device and the Life Sciences Industry

by Merit Solutions | Jan 8, 2020 | Enterprise Mobility, Life Sciences

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...

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