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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.
What is the FDA guideline for vendor qualification?
Criteria for evaluating supplier performance Quality of products or services. Delivery performance. Cost competitiveness. Supplier reliability and risk management. Communication and responsiveness.
What is the vendor prequalification process?
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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Engaged for at least five (5) years providing services in a similar capacity as requested. Include a statement indicating the date the company was founded, how
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