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| CFR Part 11-konformes Computersystem für medizinische Beschichtungsanlagen Ralf Pieterwasa und Hans-Peter Vogelsb IGH Automation GmbHa, Nottuln-Appelhülsen, und LTS Lohmann Therapie-Systeme AGb, Andernach Computer System Conformable to CFR Part 11 for Medical Coating Devices Key words Biometrische Verfahren • 21 CFR Part 11 • Chargenrückverfolgung • Dokumentation • Elektronische Unterschrift • Qualifizierung • Validierung In the following article a computer system for a coating device is presented. It covers formulation management as well as control and documentation of the production. The system’s concept is based on 21 CFR Part 11; biometric techniques are used to generate electronic signatures and to secure data integrity as required. The batch documentation, completely generated by the system, provides an optimal cost-benefit relationship. Aspects of the use of biometric techniques in the production and qualification of the computer system are discussed. |
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pharmind 2004, Nr. 6, Seite 797
