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How Do Life Science Companies Qualify Vendors and Software?

Vendor Qualification is going to depend on your own requirements. You need to establish that the vendor meets the requirements of your Service-Level Agreement (SLA).

What goes in the SLA is important and it needs to have an appropriate level of documentation, processes, and experience around infrastructure. Good qualification, data centers, and security procedures need to be formally documented and approved. Verify that there are redundancies in place such as correct document management systems, disaster recovery systems, and back-up systems.

Vendor Qualification can be viewed in two ways. You can either preform vendor audits to specify that you need these items or to find out if they have them, or you can engage other companies to do that for you. You can state in your SLA that the vendor must have these items in place in order to be considered a vendor.

There are three factors to consider. First, the Systems Qualification can be leveraged by the vendor’s efforts that they have already done from a qualification and a maintenance perspective. Next, do your validation the same as a hosted system with functional requirements and testing those according to risk. The third piece revolves around maintenance. It includes analyzing the communications that come out on a periodic basis to make sure that the risks are mitigated according to the testing.

ServiceMax has a vendor audit program internally that can be provided to clients that are in a regulated industry. Clients have used them and all of the good manufacturing or good software development practices are all documented for use in that qualification or vendor audit process.

The USDM Life Sciences Cloud Practice is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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