Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness


The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Design and development of PANalytical systems is done according to ISO9001:2000, ISO14001:1996 and CMM level 3 certified processes and procedures. These formalized processes and procedures include standards for all aspects of the development process, used in each project and safeguarded by PANalytical’s quality control organization.