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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.

Integration of PANalytical systems in a 21 CFR Part 11 compliant laboratory environment was straightforward because PANalytical offers tools and services to guarantee authenticity, integrity and confidentiality of electronic records and electronic signatures. Also the final system qualification is supported with products and services.