Drug Development, Medical Devices, Therapy Area

Supporting the Pharmaceutical Industry, 21 CFR Part 11 Compliance Readiness

By Malvern Panalytical

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 are done according to ISO9001 and ISO14001 certified processes and procedures.

These formalised processes and procedures include standards for all aspects of the development process, used in each project and safeguarded by PANalytical’s quality control organisation.

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