Abstract
For years, the biomedical industry has enjoyed the convenience of computers to collect, store, and summarize data. Validation documentation was probably not maintained for most older software programs currently in use. In this case, retrospective validation may be an alternative to revalidation. This entails documenting historically the relevant events and testing performed to prove in a convincing manner that programs were adequately validated prior to use.
The approach McNeil Pharmaceutical has taken to retrospectively validate one of their computer systems in use since 1979 is described. The outcome was a retrospective validation document consisting of 11 sections: Introduction, Summary, Background, Computer Validation, Raw Data Retention, Program Operations, Hardware, Inspection/Audits, Training, Conclusions, and a Signature Page.
Retrospective validation takes some time and hard work, but if the results are positive it can save a firm a lot of unnecessary time spent revalidating an existing system that has been operating successfully for years.
Get full access to this article
View all access options for this article.