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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.