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


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