Like-For-Like Changes: Is Validation Testing Needed? Validation Case Study #7

摘要

This case study describes several examples of improper installation of like-for-like equipment that caused significant problems for the manufacturing site. Like-for-like changes are generally assumed to be of no consequence. However, improper installation of such equipment can have serious ramifications including product recalls. Validation managers agreed that all changes, including like-for-like changes, should be evaluated by the site VAC to standardize evaluation and decision processes. Documentation requirements attesting to correct installation of high-risk, like-for-like equipment can be accomplished by a simple approved memo that is filed with the documentation request.