21 CFR Part II compliant XRD software

Monday, 20 June, 2005 | Supplied by: http://www.panalytical.com/



PANalytical has introduced software for its x-ray diffraction (XRD) systems that enable them to fully support 21 CFR Part II compliance in the pharmaceutical (and related) industries.

The US Food and Drug Administration's 21 CFR Part II regulations governing the use of electronic records and signatures relate to almost all processes in the pharmaceutical industry, including manufacturing, development and sometimes even research processes.

As PANalytical's x-ray diffraction systems play important roles in providing qualitative and quantitative phase information on pharmaceuticals, the company ensures that these systems also support the requirements for the regulations by introducing PANalytical Audit Trail software and upgraded versions of X'Pert Data Collector, X'Pert HighScore (Plus) and X'Pert Explorer Add-ons.

The upgraded packages are all designed to work in a 21 CFR Part II Support mode, providing common audit trail functionality for networked XRD analysis environments. Working in this support mode guarantees authenticity, integrity and confidentiality of electronic records and signatures. The audit trail functionality allows easy integration of PANalytical systems into 21 CFR Part II compliant laboratories.

The electronically stored data in combination with the audit trail functionality of the software packages assures complete traceability of operational settings, experimental data and analysis. Audit trail records are generated automatically, ensuring the traceability of all important data from the unique instrument identifier and set-up details right through to a complete history of all parameters used to produce the analytical results. Operating system and network tools assure security while the audit trail functionality detects any changes to electronic records, guaranteeing tamper-proof data.

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