This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way!
Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, it is your responsibility to ensure their compliance. This reality, however, should not deter you from adopting cloud-hosted systems, as their benefits are undeniable. Rather, be smart about how you select and manage them.
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
To make the most of the cloud, while maintaining regulatory compliance, you need a robust cloud vendor qualification procedure and a regulatory expert involved in your contract negotiations. Key topics include:
- Physical security
- Data security, privacy, and confidentiality
- Technical support, including enhancements
- Uptime, including backup and recovery
- Data mobility
- Regulatory compliance, especially change control
- How the cloud vendor qualifies the cloud vendors it uses (e.g., data centers)
Additionally, be thoughtful about which tools you use in your cloud vendor qualification process, aligning the tools with the criticality of the system being selected. And, finally, ensure you have the appropriate application-level and quality assurance procedures in place to support the use of each system, once it has been validated and release for production use.
And that’s it! You made it through the series. If you haven’t yet downloaded your copy of the guide on this topic, be sure to fill out the form below. If you have any questions about any of the content of these posts or the guide, or if you need help assessing and resolving compliance issues with cloud vendors, please let us know! We always love hearing from our readers.