Introduction to IVT Network’s Cloud Computing Series | IVT

Welcome to the introductory article on cloud computing for the Institute of Validation Technology’s new online IVT Network. The IVT Network will publish a monthly online article on cloud computing topics that may be of interest to the IVT community. We hope to use IVT Network as a forum to encourage discussion amongst quality, IT, and validation professionals. Topics will include review of industry standards, guidance, and other regulatory activities related to cloud computing, the challenges of utilizing cloud computing platforms and Software-as-a-Service (SaaS) vendors, and discussion on new technologies and trends.

Why will we be publishing monthly articles on cloud computing? As we all know, cloud computing has become much more prevalent in recent years as companies and organizations look to improve IT computing efficiencies, cut IT related costs, as well as maintaining systems and processes which assure the integrity of electronic records. As with any new technology, cloud computing offers many potential advantages that will further drive its expansion and use within the life sciences industry. The United States Government is promoting the use of cloud computing as a mechanism to reduce costs improve operational efficiencies. So… like it or not, cloud computing is here to stay and we, as quality, IT, and validation professionals need to understand the benefits and the risks associated with the use of cloud computing environments.

Topics which we are planning in the upcoming months include:

  • Regulatory standards and guidance related to cloud computing
  • Review of proposed cloud computing National Institute of Standards and Technology (NIST) standards 
  • Considerations for validating Software-as-a-Service applications
  • Review of SSAE-16 and SAS 70 requirements
  • Risk based approaches for use of the cloud
  • Auditing of data centers and cloud computing environments
  • Service level agreements
  • Case studies for use of SaaS and cloud computing environments.

We plan to solicit input from life sciences companies, technology vendors, and regulators as we develop articles for this series. If you have any suggestions or recommendations for upcoming articles or topics, please let us know. We may even ask you to be a guest author to write an article that will be published on IVT Network. 

The life sciences industry has faced many technological and regulatory challenges in the past, including the year 2000, promulgation of 21 CFR Part 11 and Annex 11 regulations, the use of virtual machine computing environments, and the advent of mobile computing applications. It hasn’t always been easy, but with the collaboration of industry, regulators, and technology vendors, these challenges have been successfully met. We hope to use IVT Network as a venue that will enhance industry understanding of the benefits and risks of utilizing cloud-computing environments. 

As quality, IT, and validation professionals, we know that cloud computing isn’t coming; it’s already here, and it is here to stay. We need to work together to make sure cloud computing technologies are well understood and that appropriate controls are established to assure the integrity of electronic recordkeeping, which is the basis of regulatory agencies ability to assure the safety, efficacy, and quality of drugs, medical devices, and other products.

Next month’s article will discuss basic considerations on cloud computing environments. We hope you enjoy the series!


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