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Control of Documents & Records
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A documented Purchasing Process
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Systems to safeguard against counterfeits
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Verification of Purchased Product
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Identification and Split Lot Traceability
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Preservation of Product
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Inspection of Documentation
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Evidence of Conformance
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Control of Non-Conforming Product
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Mandating of Flow-Down Requirements
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Records of Annual Surveillance by -
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independent third party quality auditors
