Technical Documentation: System Validation BRAVO
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This document introduces the system validation of "BRAVO." It includes information on "Performance Qualification," "Data Integrity," and "Ready-to-Use System Qualification." The optical system of BRAVO is designed to achieve the highest standards of accuracy and can meet the stringent performance evaluation criteria set for benchtop devices (Ph.Eur.) and quantitative analysis (USP). [Contents] ■ Concept ■ Validated Solutions ■ 21 CFR Part 11 and Beyond ■ Performance Qualification – USP <858> & <1858>, Ph.Eur. 2.2.48, JP 2.26 ■ Data Integrity ■ Ready-to-Use System Qualification *For more details, please refer to the PDF document or feel free to contact us.
- Company:ブルカージャパン オプティクス事業部
- Price:Other