Micromeritics Confirm Software for the 21 CFR Part 11 Environment
28 January 2005
Micromeritics confirm software was developed to address the many requirements specified by the 21 CFR Part 11 Final Rule published by the U.S. Food and Drug Administration (FDA) to reduce time to market of new pharmaceutical products. This confirm software is now offered with a Micromeritics suite of products that include: the Saturn DigiSizer® 5200 High Resolution Laser Particle Size Analyzer, ASAP™ 2020 Accelerated Surface Area and Porosimetry System, TriStar™ 3000 Surface and Porosimetry Analyzer, Gemini™ V Series Surface Area Analyzers, and Elzone® II 5390 Particle Size Analyzer.
Combined with Micromeritics' IQ and OQ services, the user can be assured that each system is validated for accuracy, reliability, consistent intended performance, and provides safeguards to protect the integrity of analysis records. System access is limited to authorized individuals. Secure, computer-generated, time-stamped audit trails are an integral part of the software program.
