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| FDA 21 CFR Part 11 Compliance |
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| Brinkmann® Instruments offers a unique
software and hardware solution for FDA
21 CFR Part 11 compliance. |
| tiamo™
software sets new standards for GMP, GLP, and FDA compliance. The latest quality standards and validation
procedures have been used during the development and programming of the software. In fact, tiamo has
been designed to comply with the demands of FDA Regulation 21 CFR Part 11 and its customer-specific
interpretations. |
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| For 21 CFR Part 11 compliance, we recommend the use of the Metrohm
Titrando®—a revolutionary new concept in titration. The Titrando has unique GXP features;
for example, each dosing unit communicates the titrant concentration and standardization history to
the Titrando, so there is no possibility of using the wrong titrant. The titration method is executed
from a computer—there are no buttons on the Titrando—thereby preventing unauthorized method
changes from a keypad before, during, or after an analysis. In conjunction with tiamo software, the
Titrando is the paramount solution for a 21 CFR Part 11-compliant titration solution. |
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| For more information, please e-mail us at 21CFR@brinkmann.com. |
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