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Validation of Commercial-Off-the Shelf ( COTS ) Software
| Content Provider | Semantic Scholar |
|---|---|
| Author | Brower, George N. |
| Copyright Year | 2000 |
| Abstract | 318 In the last few years, especially since the FDA’s new Quality System Regulation was finalized in 1997, and with the phase-in of the design control regulations June 1, 1 9 9 8 , many individuals in the medical device and pharmaceutical industries have been confused about the requirements for validation of C o m m e r c i a l O ff-the-Shelf (COTS) software. The questions frequently asked range from, “Is validation required?” to “How does a company even begin to do COTS software validation?” This paper discusses COTS software in general and which COTS software must be validated specifically. The FDA’s requirements for validation are itemized, followed by a description of an approach to the task of software validation for the various types of COTS software. Suggestions as to how the costs may be mitigated are presented and, finally, this paper discusses vendor auditing and what to do if a vendor does not allow an audit when one is called for. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://community.learnaboutgmp.com/uploads/db7093/original/1X/b83516fe3b7030b4eb348cf2e754b682d16de658.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
