Part Two: Life Sciences Companies and the Value of the Cloud

Article title
logo

In part one of this blog, we discussed some common misconceptions about Cloud computing for life sciences companies. We also talked about some of its benefits. This time around we’re going to look at  a few more misconceptions and highlight the value of the cloud for helping life science companies get a better handle on edata.

Misconception #6: Maintaining your Cloud in a Validated State is Impossible

As long as you’ve understood the impact the provider’s systems and infrastructure have on your validation strategy, then you can create controls to ensure your private cloud remains in a validated state.   Anticipate the need to collaborate with the cloud provider on change controls with the introduction of hardware or software modifications.  Again, you can set these expectations, and probably garner more cooperation, if you incorporate such considerations into your vendor selection criteria.

Misconception #7: A Cloud Environment does not Allow the Segregation of Information

As mentioned in Misconception #1, there are a variety of cloud environments. Private clouds are the best solution to manage data in regulated industries. They give you the most control and security because you can limit who has access to your computing environment.

With a private cloud you’re also able to set up different channels for each information group and create boundaries with respect to your regulated information. These channels allow you to “segregate” your data, establish controls and set permissions.  Virtual machines can also serve a similar purpose.

Misconception #8: FDA Regulations Related to Validation do not Apply to Clouds

A third party hosted cloud environment does not excuse you from regulatory obligations that would otherwise exist if you were hosting the services inside your company.   The same goals and strategies you apply to your local infrastructure should be applied to your cloud environment. FDA regulations can be met; you just have to be aware of the applicable risks, the controls for mitigating those risks and the right partner to assist you.

Summary

When you’re in the process of developing your Life Science cloud environment, a detailed risk assessment will be critical to your success and security. Your risk management plan should:

  • Include a complete vendor audit
  • Outline the operational processes and procedures of the cloud environment
  • Identify any major security and privacy risks
  • Consider business, financial, compliance and intellectual property risks
  • Document risk management strategies
  • Provide recommendations to improve the security and on-going compliance

Conclusion

Because you are ultimately responsible for your data’s authenticity, veracity, and security, establishing compliance boundaries and conducting periodic analysis of the technology environment is imperative. Be sure to define your validation and regulatory requirements so they apply to your cloud solution.

Whether you are an early adopter or are fighting virtualization every step of the way, cloud computing is here to stay. Shifting your technology operation to the cloud includes benefits, such as:

  • Improved scalability, both up and down
  • Increased access to and utilization of key business assets
  • Improved controls on security and data access
  • Increased innovation due to collaboration and availability of resources

Although cloud computing isn’t without it’s difficulties, it’s definitely a viable option for Life Science businesses. To ensure a successful implementation:

  • Perform a complete vendor audit
  • Outline the operational processes and procedures of your cloud environment
  • Identify any major security and privacy risks
  • Consider business, financial, compliance and intellectual property risks
  • Document risk management strategies
  • Provide recommendations to improve the security and on-going compliance

If you missed Part I of this series, you can read it here.

About the author:

Russ King is President of Methodsense, a consulting firm that helps clients deliver medical and technological breakthroughs by effectively meeting the requirements needed to bring their products to market.  They guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions, enabling clients to operate more effectively during the commercialization process and beyond. MethodSense is located in the heart of Research Triangle Park, North Carolina – home to one of the world’s largest biotechnology clusters and a hub for technology-based innovation.  We invite your communication: Russ King, (919) 313-3962 or rking@methodsense.com.

Summary
Part Two: Life Sciences Companies and the Value of the Cloud
Article Name
Part Two: Life Sciences Companies and the Value of the Cloud
Description
In part one of this blog, we discussed some common misconceptions about Cloud computing for life sciences companies. We also talked about some of its benefits.
Author
Publisher Name
AssurX
Publisher Logo
article_logo
Comments
pingbacks / trackbacks

Leave a Reply

One Platform. Every Solution.
AssurX Quality + Compliance ManagementA single versatile system can improve quality, compliance and streamline workflow
Don't Miss A Post

Subscribe to our blog to receive an email when we publish new content.

Recommended posts
Recent Posts
Categories
One Platform. Every Solution.
AssurX Quality + Compliance ManagementA single versatile system can improve quality, compliance and streamline workflow