Life Sciences

Tips And Best Practices For Compliance In The Cloud

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of the park.

Cloud Vendor Qualification Tools

When qualifying cloud vendors, there are several tools you can use including audits, questionnaires, investigating publicly available information, and checking references. Because audits are time-consuming and expensive, you might want to reserve them for systems you deem “critical.” For less-critical systems, reviewing a completed questionnaire might be sufficient.

To conserve resources, you will want to use a risk-based approach when selecting qualification tools. Consider defining system criticality tiers somewhere in your SOPs, and then creating a kind of matrix that aligns the types of qualification tools with each tier of criticality.

The Digital Essentials, Part 3
The Digital Essentials, Part 3

Developing a robust digital strategy is both a challenge and an opportunity. Part 3 of the Digital Essentials series explores five of the essential technology-driven experiences customers expect, which you may be missing or not fully utilizing.

Get the Guide

As a point of clarification, the topics you cover in your qualification process will be the same across all cloud vendors/systems. What will differ is the set of tools you use to learn about those topics.

Additional SOPs

Your cloud vendor qualification SOP will help you select an appropriate system for regulated purposes, but is not the only SOP you need for a service in the cloud. As with any regulated software or hardware, you still need documented procedures that address business use and quality assurance (QA), especially computer system validation (CSV) and change control.

As a general guide, the cloud vendor will own the technical procedures (which you will qualify during cloud vendor selection and enforce in your SLAs), and you will own the application procedures, with quality assurance procedures overlapping.

Okay, almost there! Just one last post in this series. If you haven’t already, feel free download the guide on this topic by filling out the form below. See you soon!

About the Author

Param Singh has been working in the life sciences industry his entire career. As the director of clinical trial management solutions at Perficient, he developed the clinical trial management team to become one of the best in the industry. Param leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. He has a knack for resource and project management, which allows clients to achieve success. Param has been with Perficient, via the acquisition of BioPharm Systems, since 2008. Prior to joining the company, he guided the clinical trial management group at Accenture.

More from this Author

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.