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Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
BACKGROUND:
Computer systems used in the production and control of drug products can consist of
various devices (hardware) and programs (software) supplied by different vendors, or in
some cases by a single vendor. It is important that such computer systems perform
accurately and reliably, *and* that they are suitable for their intended use.
Questions have arisen as to the vendor's responsibility in assuring computer systems
performance and suitability. When an integrated system, composed of elements from several
different vendors, fails, it can be especially difficult to attribute the cause of a
problem to one particular vendor.
POLICY:
The end user is responsible for the suitability of computer systems (hardware and
software) used in manufacture, processing or holding of a drug product.
*The vendor may also be liable, under the FD&C Act, for causing the introduction of
adulterated or misbranded drug products into interstate commerce, where the causative
factors for the violation are attributable to intrinsic defects in the vendor's hardware
and software. In addition vendors may incur liability for validation, as well as
hardware/software maintenance performed on behalf of users.*
*Material between asterisks is new or revised*
Issued: 1/18/85
Revised: 9/4/87