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300 Chapter 10 • Global, Ethics, and Security Management

•Establish and maintain records of acceptable suppliers, contractors, and consultants.
•Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or
reference the specified requirements, including quality requirements, for purchased or otherwise
received product and services. Purchasing documents shall include, where possible, an agree-
ment that the suppliers, contractors, and consultants agree to notify the manufacturer of changes
in the product or service so that manufacturers may determine whether the changes may affect
the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.

EXHIBIT 1-1B 21 CFR Part 820.50—Quality System Regulation.

Vendor
Possible
Phase Deliverable in Package Comment
Planning Change control form
Planning Business requirements
Planning Compliance assessment report May have position
papers
Planning Validation plan M See below
Requirements User requirements T See below
Requirements User acceptance test plan/cases T Should be developed at
this stage
Requirements Product functional specification E See below
Configuration Configuration specifications T See below
Install/Test Installation plan and qualification T Installation qualification
expected
Test System/operational test protocol E If required
and report
Test System performance test T See below
protocol and report
Test Validation report T Possible, but not likely
Use User manual E Manuals and SOP for
system expected
Use Support plan/contract E If required
Cross Traceability matrix M

VENDOR DEVELOPMENT
Planning Quality/project plan These should be
available for review as
part of a vendor audit
Requirements Product requirements
Design Design specification
Develop Program standards