Cloud Computing

Cloud computing: A smart move for FDA-regulated businesses?

by | May 11, 2021 |

As recent as five years ago, biotech and pharmaceutical companies were apprehensive about operating FDA-regulated business applications - like finance and operations - in the cloud. The concept of SAAS ERP or cloud computing was not only daunting, but it also raised a lot of questions. But now the tide has turned, and life science manufacturers are embracing cloud computing, viewing it as not only a smart move but a necessary one. Here are three reasons why cloud computing can be a smart move for FDA-regulated businesses: 1. Cybersecurity  Five years ago, when we still flew around the world on airplanes, I sat next to a cybersecurity expert making his way from San Francisco to Paris in an emergency response to a global 500 company that had been hacked. The hackers had been inside...

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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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CapEx Vs OpEx: Cloud Computing

by | Apr 18, 2018 | ,

Traditionally, IT expenses have been considered a Capital Expenditure (CapEx). Today, with the move to the cloud and the pay-as-you-go model, organizations have the ability to stretch their budgets and are shifting their IT CapEx costs to Operating Expenditures (OpEx) instead. This flexibility, in accounting terms, is now an option due to the “as-a-Service” model of purchasing software, cloud storage and other IT-related resources. Cloud computing made simple When it comes to cloud computing, organizations now treat IT services as a utility like water: products or services supplied by a vendor that is paid for as you consume it. And while you and I may not know how to build or manage water treatment plants or distribution systems, we assume our vendor is providing us water that is safe...

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