Summary of Society of Quality Assurance (SQA) 2015 Annual Meeting

May 01, 2015 | jing.to@veeva.com

Is Quality Ready to Embrace Cloud?

Over 800 quality professionals attended the Society of Quality Assurance (SQA) 2015 annual meeting. There was a lot of interest in cloud/SaaS with several presentations focused on the topic. Veeva, in partnership with Quintiles and an emerging biotech, had the unique opportunity to host a series of sessions on cloud computing exploring regulatory, validation, and implementation implications. Highlights included:

Quintiles Advisory Services, John Rogers, lead a discussion on regulatory requirements for compliant and validated applications and considerations for cloud:

FDA 21 CFR and EU Annex 11 validation requirements

Architecture changes with cloud and implications for compliance, and

Guidance on validating applications including a risk-based approach

Next, Veeva examined best practices for validating cloud applications, specifically looking at:

Cloud validation lifecycle

Division of roles and responsibilities between vendor and customer, and

Recommended vendor supplied validation supporting documentation

Finally QA Manager at Medicines360, Kevin Loftus, provided a customer perspective on the implementation and validation of a cloud application – Vault QualityDocs. Working with vendors that build applications specifically for life sciences, drastically shortens project timelines. Kevin also reviewed:

User requirement specification and GxP risk and system impact assessment

Validation master plan

Establishing application controls, and

Business impact with cloud

Summary of Society of Quality Assurance (SQA) 2015 Annual Meeting

Interested in learning more about how Veeva can help?