ABSTRACT
Pharmaceutical and healthcare companies still have substantial concerns over the most appropriate way to address the organization of validation and how to enable management to fulfill its responsibilities. This chapter suggests a typical approach that satisfies a company’s accountabilities. However, in presenting this offering we do not purport to suggest that this is the only acceptable approach. The needs of pharmaceutical and healthcare companies will vary since they depend on many different factors, including the scope of the validation requirement, the availability of suitably skilled corporate and contract staff, and cost.
