Nowadays, although there are some who are still in the denial stage, the level of grief is more subdued, and the industry is more accepting. For many, computer validation has become a part of daily life, just like accepting and using the mandatory car seatbelt. The road to acceptance was not without its controversies. In the mid 1990s, many varied opinions led to confusion about the scope of computer validation. At one point, a computer's operating system (OS) was thought to be in scope and to require validation, and the OS vendor had to be audited. In another case, a consultant advised that a "change control" must be filed when replacing a printer's toner cartridge (now we know that consumables don't need change control). It was during this period of confusion that "common sense" became the buzz phrase and "it depends" were the first two words that preceded an answer to any computer validation question.

We have transitioned from the "common sense" and "it depends" environment to a risk-based and risk-management environment, especially since the US Food and Drug Administration is on board with risk management (2). We hope that a risk-management approach will level off the inconsistencies inherent to the "it depends" approach. Only time will tell whether it will be successful. By this transition, however, it seems that along the way we have inadvertently proved Darwin's theory of evolution: we have evolved and transitioned from a less-structured environment to a more technically structured and scientifically minded methodology to computer validation.