Assists with compliance to FDA regulation that data systems be validated for accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records
Micromeritics announces the release of Confirm software for its Gemini and TriStar surface area and porosity analysers.
The all-new software was developed to address the many requirements specified by the 21 CFR Part 11 Final Rule published by the US Food and Drug Administration (FDA) to reduce time to market of new pharmaceutical products.
Confirm software assists with compliance to FDA regulations that require all data systems be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
System access is limited to authorised individuals. Secure, computer-generated, time-stamped audit trails are an integral part of the software program.
Micromeritics's Gemini series instruments perform single-point and multipoint BET and Langmuir surface area measurements, as well as total pore volume analysis using an adaptive dose rate, static volumetric measurement technique.
The TriStar multiport surface area and porosity instrument allows simultaneous and independent analysis of up to three samples of similar or greatly different characteristics.
