Ellab ValSuite Software

Ellab ValSuite Pro Software

The ValSuite Software Packages are working on a database platform and therefore securing highest compliance to FDA 21 CFR part 11  Validation Report & Guide with IQ, OQ available

Easy data collection for both real-time and wireles systems in the same data sessions

Temperature, Pressure, Deflection, RH%, Lethal Calculations, Time, Min/Max Values simultaneouly

Compliant to FDA Guidelines

•      Raw data is built into a database structure and cannot be modified or erased.
•     Complete audit trail with easy search engine to find data by date, session, user and module.
•     User ID and passwords with detailed user access control.
•     Sensor ID provides complete NIST traceability.
•     Customized report generator eliminating need to export data.
•     Specific compliance reports (e.g. EN554).
•     Automated pre and post calibration reports.
•     Print preview feature with report output in pdf file format.

Valsuite user profileSetting user profiles

Ellab ValSuite Security system uses the Access Manager function to define users and configure their rights.

Only Administrators can set up the Access Manager parameters for the users.

The administrator using the profile function defines user rights and access points.

Any privileges left un-check marked by the administrator will not be visible to the User when he/she is logged in.

Audit Trail

Audit TrailEllab defines an audit trail as “a record showing who has accessed a computer system and what operations he or she has performed of critical change during a given period of time.”
The Valsuite software meets the guidelines for electronic signature as specified in FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signature.
• SQL database solution.
• Three levels of identification – Session name / ID, User ID and password
• Signature identifies the user, and includes: Date, time and category of action.

Temperature Extrapolation

ValSuite supports extrapolation of the temperature User calibration, so you are able to extend the adjustment 5 degrees Celsius beyond the outer calibration points.

In a one point calibration there is extrapolation in the Whole Temperature range.

General settings

Purpose for the general setting is to setup the basic setting for the system, like temperature, pressure, Relative Humidity, Rotation, Deflection, Lethality, Heat Penetration, Time and Logo.

Temperature
Valsuite supports 3 different temperature units:
– Celsius
– Fahrenheit
– Kelvin

Valsuite supports 6 different pressure units: – Bar / Mbar / psi / kg/cm2 /  hPa / kPa

Humidity : RH %

Time : Relative and Absolute

Lethality : Fo, Po, Ao, and Co values

Can Select ‘ D ‘ values

Logo : can select default Ellab logo or custom logo whcih can be printed in all the validation documents

Comments

It is possible to add text comments and include pictures  / photos of the processing machines in the comment box

The comments will be prepared with data as show in the given picture.

Limit Report

The Limit report is able to analyze the Data in a Session, in a very simple and efficient way.

The report sets up a Test scenario that can give the result of Success or Fail.

Can answer questions a like:
Is there at least one sensor that obtained a Lethality Value of 15 or higher?
Did all the Sensors measure between 121 and 124 in the Holding time?
Which sensors that did not reach the sterilization temperature?
Did all Temperatures fulfill the Saturated Steam condition in the Holding Time?

Saturated Steam test

The Saturated Steam Test checks the maximum deviation between a pressure Sensor and the Temperature Channels converted to a pressure according to the steam table.

Validation Report

The validation report is an open platform. All report modules can be selected or deselected to create a custom designed report. The individual parameter values can be changed to local values.  The definition of the different parameters directly refers to the EN 554 norm, and we have template their coved EN17665/EN554

Typical use of Report :-
Qualification of Autoclaves
Heat Distribution studies
Heat Penetration study with saturated steam condition

Advanced Validation Report
The Advanced Validation Report is an open platform. All report modules can be
selected or deselected to create a custom designed report. The individual
parameter values can be changed to local values using the small arrows, or by
directly entering new values. The report can be saved as a template.

Typical use :
Heat Distribution Studies
Heat Penetration Studies
Analyze Studies where temporary drops out of the Sterilization Band exist.
Analyze Studies with asymmetric Sterilization Band.
Analyze studies where phases are manually controlled with Time Markers

Dry/Wet Report
ValSuite supports RH% calculation, according to wet and dry values.
Typical use :  Calculate Relative Humidity and Dew point from a dry and a wet temperature.

Statistics Report
Typical use : Use statistical functions to prove a correct process.

Min: The Minimum Value
Max: The Maximum Value
Average calculation: The average value (arithmetic mean) is the sum of all measurements divided by the number of measurements.

Delta

Standard Deviation

Max-Average:  Xma=Xmax-Xaverage
Average –Min: Xam=Xaverage-Xmin

Select the desired statistical output.
Global Representation—statistical functions are presented graphically on the screen and in the report
Each Series—statistical functions are presented in the report for each sensor
Global—statistical functions are presented in the report globally for all sensors

Air Leak Report
Typical use : Vacuum test of Autoclaves.

Graphic Features – Zoom

Adds & Reports