The software is validated by our company to reduce the validation required by the user. It complies with 21CFR Part11 in terms of safety of results. Login management and administrator / operator authority setting functions are built into the software. The software also has the function to log operations.

We will respond as follows in Japan. For customers outside Japan, please contact our sales department or distributors.
1. IQ and OQ can be performed at the time of equipment installation.
2. Equipment validation can be performed through periodic check.

FDA BAM is a laboratory procedure recommended by the US Food and Drug Administration (FDA) for microbiological analysis of foods and cosmetics.
With the PSF series, both the number of significant digits and its range can be set.

ISO7218:2007 is a general requirement and guideline for microbiological testing of food and animal feed presented by ISO (International Organization for Standardization).
With the PSF series, the number of significant digits can be set, and the effective measurement range can be set. It has a function to call the user's attention for measurements outside the range. In addition, the measured data of samples with different dilution ratios can be calculated collectively.

ISO 4833-2:2013 specifies a horizontal method for enumeration of microorganisms that are able to grow and form colonies on the surface of a solid medium after aerobic incubation.
It is a method presented by ISO (International Organization for Standardization) for microbial enumeration of food, feed and environmental samples related to their processing.
The PSF series complies with ISO4833.2 in the flat plate method and spiral plate method.

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories that carries out the clinical tests (general tests, hematological tests, biochemical tests, immunological tests, microbiological tests, pathological tests, etc.).
In the PSF series, the validation procedure is clarified, and the result can be judged.

AOAC977.27 is a fertilizer inspection method proposed by AOAC (Association of Official Analytical Chemists).
The PSF series complies with AOAC977.27 in the flat plate method and spiral plate method.

It is a standard method proposed by the American Society for Clinical and Laboratory Standards for antimicrobial susceptibility testing. This method is also used in Japan.
With the PSF series, the sensitivity measurement result can be judged, and the threshold value can be input/edited by the user.

It is the standard method proposed by the European Commission for the Study of Antimicrobial Susceptibility Testing for antimicrobial susceptibility testing.
With the PSF series, the sensitivity measurement result can be judged, and the threshold value can be input/edited by the user.

NF V08-100 is a standard of the French national organization for standardization(AFNOR).
With the PSF series, the number of significant digits can be set and its range can be set.

XP V08-034 is a standard of the French national organization for standardization(AFNOR).
With the PSF series, the number of significant digits can be set and its range can be set.

It can output the results as excel format, and measurement conditions as xml format. For import a format to LIMS, please contact to the LIMS provider.