Prequalification Criteria for Vendors 2025

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FDA 21 CFR 211 requires vendor qualification as a part of the validation process, and typically it is accomplished by composing a checklist to assess vendors for their ability to fulfill lab requirements. The following requests are typically made during new vendor qualification: Summary of their Quality Systems Program.
Criteria for evaluating supplier performance Quality of products or services. Delivery performance. Cost competitiveness. Supplier reliability and risk management. Communication and responsiveness.
It involves a set of criteria tailored specifically to assess a vendors ability to provide goods or services. Qualified vendors are then shortlisted as potential candidates who can respond to future bids and procurement requests.
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