ABSTRACT

The control systems associated with building environmental management, typically known as building management systems (BMSs), have always presented a difficult challenge to those responsible for the validation. Although the equipment involved may well be straightforward to validate on their own, the control systems themselves have presented a more difficult challenge. This has been because cGMP and noncritical facilities are generally housed in the same building. The control systems therefore have generally been mixed, thus making it very difficult and expensive to validate. Segregating the control system between cGMP and noncritical is also very difficult because the air-handling equipment and other such equipment may be common to both facilities. This has led to the common generalization that “BMSs can not be validated,” the common get-out clause; however the regulators are not convinced.