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.

Integration of PANalytical systems in a 21 CFR Part 11 compliant laboratory environment is 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.

Complete traceability and reproducibility is guaranteed in terms of experiment (the XRDML data platform stores all details from unique instrument identification down to the last set-up and measurement detail), operation (automatic audit trail generation) and analysis (complete history with all parameters used to achieve the analytical results).

The proper set-up of the operating system (Microsoft (MS) Windows XP or MS Windows 2000) and network tools provide security while the audit trail software detects if electronic records are made invalid or changed, guaranteeing tamperproof data.

PANalytical also offers system validation support, comprising products for installation qualification (IQ) and operation qualification (OQ), and support for design qualification (DQ) and performance qualification (PQ).