The world's most widely recognized QA manual has been updated to provide the audit system readers need to assess their compliance with new standards and regulations and those that continue in effect. This indispensable toolkit includes checklists that simulate FDA QSIT audits. The new edition-two volumes plus a software package-continues a two-decade tradition of providing expert guidance on performing successful audits and provides easy, objective, and quantifiable results for management track and trend compliance. Comprehensive in its coverage, this practical guide is an invaluable resource that offers effective training for new auditors and updates current auditors on new standards and regulations.




