FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

FDA CDER/ORA Compliance Policy Guide Sec. 425.200 “Computerized Drug Processing; Vendor Responsibility” (CPG 7132a.12) revised 4-Sept-87. Establishes end user responsbility for validation/suitability of vendor supplied hardware and software used in Drug manufacturing, holding or processing and identifies conditions under which the vendor may also be liable including if they perform hardware/software maintenance on behalf of the users.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation, supplier, COTS, OTSS

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