Find a solution that takes a holistic approach to your regulatory requirements.
Learn what the qualification process involves and why it makes sense to outsource it.
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What is vendor qualification? First and foremost, it’s a critical aspect of your overall risk-reduction strategy. More than just an audit, vendor qualification is an evaluation of their product or service and a comprehensive assessment of their ability to fulfill your requirements.
Cloud vendor qualification: Do it yourself or outsource it?
Organizations regulated by the U.S. Food and Drug Administration (FDA) are required to have documentation showing that software products and cloud services purchased from vendors meet company standards and are fit for the intended use. During the qualification process, you need to research vendors and find out if they meet your needs, then prepare for and conduct an audit. Or, you can engage a company like USDM Life Sciences to do the work for you.
From initial validation to ongoing maintenance of system updates, patches, and changes, USDM Cloud AssuranceTM handles your cloud vendor management. Vendors in the Cloud Assurance ecosystem undergo an annual audit of their design, development, testing, qualification, and maintenance methodologies. Audit results are compiled into a vendor assurance report that provides a summary of the audit and cites all source material. The report can be used as defensive evidence for the FDA.
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What are some advantages of outsourcing vendor qualification?
The time and energy required for vendor qualification can be overwhelming. Every organization has its own reasons to outsource, like choosing to:
- Mitigate risk and be audit ready
- Save time and money
- Optimize and scale for growth
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How do organizations ensure expectations are met?
Service level agreements (SLAs) define expectations between customers and vendors. They spell out what you expect from the vendor and specify metrics for measuring vendor effectiveness. They also address penalties for unmet service levels.
SLAs help verify that vendors have redundancies in place, like document management systems, disaster recovery systems, and backup systems. Additionally, data centers and security procedures are formally documented in SLAs. Before you commit to any vendor, be sure they meet your SLA requirements.
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The USDM Audit Team ensures that cloud vendor verification and validation activities align with safety and effectiveness requirements. When you’re ready to outsource your cloud vendor qualification, contact USDM.
On-Demand Event Sessions
USDM hosted its first virtual event, Forward-Thinking GxP Compliance & Process Optimization, with an all-star lineup of life sciences thought leaders. The event addressed various stages of cloud compliance maturity. Whether you are getting started, getting better, or getting ahead, this discussion will provide guidance for your cloud transformation journey.
Learn more about this topic in our session replay, Managing Your Regulated Cloud Technology.
Here are links to the other session replays and companion white papers:
Session 1 video: Your Compliance and Technology Today
Companion white paper: Top 5 Opportunities to Improve Compliance Maturity
Session 3 video: FDA Perspectives on Cloud Technologies
Companion white paper: Considering CSA? Here's what you need to know
Session 4 video: Extracting Value from Your Cloud Data and Processes
Companion white paper: Google Cloud Platform for Life Sciences and Health Technology