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Good Lab Practice (GLP) is becoming an increasingly more important aspect in the organization and daily life of
commercial laboratories. This is especially so since the Food and Drug Administration (FDA) is requiring conformity to a set of GLP rules for data used in FDA applications (21 CFR Part 11). Any research entering the commercial world will be faced with the question of how reliable data and results were acquired and stored. Is it still possible to know exactly how the data were gathered? Who was the person doing the experiment? What were the exact parameters (e.g. amplifier gain? last calibration of instruments?). Suddenly, it becomes apparent that it would be a big advantage if one had applied at least a minimal set of GLP rules.
HEKA has always set the highest standards for electrophysiological data acquisition software. Currently, academic laboratories around the world are utilizing numerous features built within our software that enable them to conduct experiments and manage data confidently and with good lab practices in mind. To comply, however, with new FDA regulations and satisfy the requirements of commercial customers, HEKA has designed the FITMASTER PRO software which can be operated in a PATCHMASTER PRO environment.
For a detailed description of the basic electrophysiology related features please refer to the FITMASTER software.
HEKA in addition offers services during the validation process. The HEKA staff helps creating User Requirement Specifications (URS) as well as performs Installation Qualifications (IQ) and Operational Qualifications (OQ) of PATCHMASTER PRO / FITMASTER PRO setups. For details please contact HEKA.
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