Cloud Computing in a Regulated Environment

How can cloud computing be used in a highly regulated environment?

 In order to appropriately manage risk, increase reliability, and manage scalability, cloud services can serve as modular building blocks to allow a software defined virtual infrastructure with high availability and high fault tolerances. However, these environments must be thoroughly defined and identified. By understanding both the cloud capabilities and limitations, users can manage quality and risk to define application and data management of GMP data in the cloud.

Sensor monitoring with Internet of Things devices (IoT) allows for real-time environmental monitoring half a world away. Quality assurance can review processes and manage material release from another continent. From their offices and mobile phones, process scientists can monitor processing, troubleshoot issues, and review manufacturing results in real time as production is taking place. 

Will it work for your company? CAI worked with a biotech startup with personalized therapies that outsourced manufacturing in Asia, managed laboratories in multiple locations in North America, and tied all of it together with electronic batch record systems and electronic lab notebook systems in the cloud in real time. To mitigate the security risks and data integrity risks that come with cloud implementation solutions, our client employed a multi-faceted approach to their cloud implementation strategy. Cloud service risks for Platform as a Service (PaaS) determined the level 0, level 1, or level 2 controls used in assessing and alleviating risk. 

Are there other opportunities? Companies are using cloud-based maintenance management systems to manage parts and equipment distribution for multiple facilities. Companies are using cloud-based applications to manage supply chains for just-in-time materials. How can your company leverage this technology?

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About the Author:

John Hannon is a seasoned project manager and consultant with over 29 consecutive years of experience in the computer based automation and IT fields of commissioning, start-up, process automation, and qualification for regulated environments.  He has extensive test generation and execution experience with a wide variety of systems and equipment.

Contact John at john.hannon@cagents.com