Life Sciences

Is Your Data Estate Maximizing its Property Value?

by | May 18, 2021 | , ,

When I hear biotech and pharma executives talk about their company’s “data estate,” I know the Microsoft and Amazon people have been meeting with them. I also think of the little British man who ran the estate on Magnum PI. His shtick was to be intimidating because his ferocious Dobermans listened to him. With just the right nod to his dogs, they would viciously attack the perpetrator.  Data as the Foundation of Digital Strategy In the past, executives looked at their IT strategy and their business apps as the ultimate foundational component. The prevailing thinking was, “How do I get all of my data into one place that is secure and enables all the workloads I think I’ll need to execute our strategies?” Increasingly, innovative biotech and pharma business executives are looking at...

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5 Considerations for Getting to a Validated, Cloud-based ERP Solution

by | Mar 30, 2021 | ,

If you produce products in pharmaceuticals, nutraceuticals, or biotechnology, your organization must maintain system validation. The FDA defines this as:  “establishing documented evidence that provides a high degree of assurance that a specific will consistently produce a product that meets its predetermined specifications and other quality attributes.” [General Principles of Software Validation | FDA] According to FDA rules, systems that enable processes that could harm or kill humans if deployed incorrectly must be validated. This impartial review is known as Independent Verification and Validation or IV&V. Validation doesn’t mean that the solution deployed is free from any defects, but it should establish confidence that the solution is tested as reliable in its performance...

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21 CFR Part 11 Compliance: What You Need to Know

by | Feb 20, 2020 |

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 wish to use an electronic business management system, like an ERP system, quality management system, and / or a quality document management system. These standards apply to all phases of Life Sciences companies, including research, manufacturing and distribution of products and services. This article covers what you need to know about 21 CFR Part 11 compliance. The FDA holds all life sciences companies and executives accountable to very stringent quality and safety standards. Companies use a mixture of electronic systems...

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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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