General

General overview of the functions and possibilities of BiosistoChart.

Access

The BiosistoChart system is offered via the Internet as a user service (Software-as-a-Service). There are no special requirements for the internet connection, except that sufficient bandwidth must be available for smooth operation and current software versions of web browsers are used.

Accounts

The use of BiosistoChart is based on a personal user account. The account grants rights to use the BiosistoChart application. No ownership rights are transferred. Each user gets a personal unique account. The account is not transferable and is strictly personal. Every customer gets a company account, which in the future, customers can maintain users themselves (create, change and delete). For the time being, Biosisto will carry out user management for its customers.

Licenses

BiosistoChart has three license types that can be purchased per customer location and laboratory:

  • Basic license
  • Company licentie
  • Proficiency licentie

Basic
All functionality for using Control Charts in accordance with the NEN 6603 standard is included in the basic license, including automatic statistical checks and handling of non-conformations. Part of the basic license is a non-conformation report, which provides a handy overview of all non-conformations.

Company licentie
All the functionality of the basic license with the additional ability to compare Control Charts between all proprietary labs. Specifically, this equation means:

  • In Control Charts, the option to make all customer locations visible
  • An Interval & Box plot with all customer locations
  • A batch report of all customer locations
  • An Interlaboratory Comparison Report (ICR) of all customer locations

Proficiency licentie
All functionality of the basic and company license supplemented with the possibility to anonymously compare data with other external laboratories.

A global overview of the functionality between Basic, Company, and Proficiency licenses:

FunctionalityBasicCompanyProficiency
Use Control and Quality Charts for your own laboratories and compare them with Biosistoxxx
Using and comparing Control, Quality, and Analysis Charts from own laboratoriesxx
Use and compare Control, Quality, and Analysis Charts from own labs and anonymously with external labsx

Basic rapports

An Interval & Box plot provides a graphical representation of, among other things, the five-number summary. This five-number summary consists of the minimum, first quartile, median, third quartile, and a maximum of the observed data. Therefore, the Interval & box plot is a simplified, useful, graphical representation of the data distribution with which laboratories can be compared.

Batch report provides an overview of all laboratories using a specific batch. The list shows the most common numbers (minimum, average, maximum, standard deviation, relative standard deviation) and several 3s exceedances) so that it is quickly visible how other laboratories score with the selected batch.

An Interlaboratory Comparison Report is a report that creates an Interlaboratory Comparison (Proficiency) report for each batch used in the selected period. On this, a statistical comparison is made per batch, strain, and method of all data from all customers, including a z-score and related relevant data;

Product license

BiosistoChart has several optional product licenses that make certain specific functionality available. These are:

Method Blanks
One or more blanks can be defined per method with a freely selectable conforming and non-conforming value. The blank can be captured immediately at each data point entered for this method. A non-conformation is automatically created when the Non-Blank is chosen.

Quality Charts
Control Charts are mainly used to register quantitative methods and colony counting. For tracking qualitative methods, including blanks, there are Quality Charts. The customer can easily indicate what conform and non-conform values are. A non-conformance is automatically created when the nonconformance value is chosen.

Customer batches
This product license allows customers to create and maintain Control Charts for their own, in-house, created batches of reference material.

Media Analysis
The ability to record the manufacturer, type, and batch number (lot number) of the media (agar) is used in this analysis when entering a BatchCount. The results are processed and displayed in the various reports. This allows statistical comparing the media used (per lot number).

Method Performance Report (MPR)
Validated analytical methods must undergo periodic revalidation based on ISO 17025. The MPR provides per method, standard, and performance characteristics based on the first-line control analyses, with which the revalidation can be demonstrated.

Histograms
With the Histograms license, a proficiency test is performed in which a direct assessment of the own performance is made compared to that of other laboratories. This is additional to the control cards and is understood as level control, also called third-line control.

User roles

BiosistoChart has several roles that can be assigned to users. These user licenses are:

User roleDescription
AnalystThe Analyst role can create Control and Quality Charts and enter data points. The Analyst role can also fill out a non-conformation form. This is the simplest role in BiosistoChart and is primarily intended for analysts to enter analysis results. This role is tied to one laboratory
Quality ControlThe analyst role is completed by closing and accepting non-conformations and managing metadata (methods, limits) to create Control and Quality Charts. The Quality Control role can check and handle non-conformations. This role is tied to one laboratory
Quality OverallThis role has the same possibilities as Quality Control but in all the company's laboratories
ViewerThis role has the same possibilities as the Quality Control, but only read rights
Customer ViewerThis role has the same possibilities as the Quality Overall but only read rights
AdministratorBiosisto is the system administrator and will manage and supplement the common data through the administrator account. Common data includes media, methods, certificates, and target organisms

Biosisto - Quality in Control

Microbiological laboratories should be able to receive reliable analysis without much overhead. A microbiological analyst must be able to focus on the primary activities, for example analysis of the sample material. Quality control should support the analyst in a logical and simple manner. By using modern information technology, process control and quality assurance are designed smarter and more effective.

Biosisto b.v.
Martin Luther Kingweg 3
9403 PA Assen, The Netherlands
www.biosisto.com

BiosistoStandard