FAQ
Validator ® 2000
Features and Capability Questions
Troubleshooting Questions
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Have the hardware and software been validated and is documentation available?
The hardware, firmware and software have been validated by Kaye Quality Assurance testing. The validation binder can be ordered using Model X6000.
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What does the FDA think about the new product?
It is important to remember that the FDA only approves drugs and medical devices and not specific validation equipment. FDA inspectors have attended some of Kaye's introductory presentations and have provided feedback which was used as part of the implementation of 21 CFR Part 11.
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Are the reports different and will the FDA accept a "new" format?
The report format is different from the Digi report format. There is a report generator which provides much more flexibility. Reports are generated in an easy-to-read style and are built from protected files that cannot be used if tampered with. Customers still have the option of importing the raw data into a spreadsheet and reformatting. All of our feedback from the FDA indicates the report format is not important to them. They are more concerned that critical parameters and data are present and signed by the employee responsible.
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How does the Validator 2000 software differ from previous systems?
The software is completely different, which is why Kaye will offer a separate training class for the new system. The software is much more flexible and offers customers many more capabilities. For example, you can perform different calculations on the same sensors. Or calculate lethality separately for heat-up and cool-down. Or group calculations using different sensors, to simultaneously run more than one qualification study. A wider range of calculations is available including intervals, standard deviation and lethality based on Z and D values.
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How many inputs will the system allow?
The Validator 2000 accepts 36 inputs in any combination of Thermocoupe, Voltage or Current inputs
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Can you load data or a program from a disk and/or PCMCIA card?
The Validator 2000 uses a standard low-cost floppy disk to perform these functions. Data can be sent to the floppy and the computer simultaneously. The PCMCIA card is not supported.
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What are the options for data storage?
Depending on the number of inputs selected, data is stored to the floppy and/or the hard disk at rates from 1 second to 12 hours. Data can also report to the printer at an independent rate. Data is stored in RAM which ensures that results are in memory and will not be lost if the floppy is full or printer is out of paper. Data is stored in secure files so that the original data can be traced back to raw readings.
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Is there a method to begin/end lethality calculations without an external switch? Will this be noted on the report?
Yes. This will be noted in the Setup report. The lethality calculation choices are:
- Min. Max or Avg value compared against a fixed number
- Entire cycle from Start Qual to End Qual
- Portion of the cycle from Start Qual to End Exposure
- Portion of the cycle from Start Exposure to End Qual
- Portion of the cycle from Start Exposure to End Exposure
- Switch
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Does the new system perform similar math calculations as the Digi?
More than the Digi Validator. Not as many as the Digi. The calculations are a subset of the functions available with the Digi and are all functions necessary for thermal validation.
The statistical calculations include:
- Max value in the group
- Min value in the group
- Average and Standard Deviation of all values in the group
- Channel number of Max and Min
- Difference between Max and Min
- Difference between Max and Avg
- Difference between Avg and Min
Interval calculations include:
- Maximum during interval (and time of Max) for each sensor
- Avg during interval for each sensor
- Minimum during interval (and time of Min) for each sensor
- Maximum of all sensors during the interval
- Minimum of all sensors during the interval
The system will perform lethality calculations as well as the saturation pressure and temperature of steam.
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What is meant by pre-calibration of sensors?
Each Sensor Input Module (SIM) where sensors are wired has a memory. During calibration the SIM remembers each sensor offset, the Validator serial number and its location in the instrument. This means that you can calibrate a set of thermocouples wired to a SIM and detach it from the Validator. When you are ready to use the SIM again with the same Validator and slot, you don't need to perform another sensor calibration. However, if you choose to use the SIM in a different instrument than originally used, you must recalibrate.
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What type of thermocouples can be used?
Type T, J or K thermocouples can be used with the system.
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Does the system offer trending capabilities?
Yes, using the PC. Trending has been provided primarily for real time viewing and not for elaborate reporting. Up to 6 variables can be graphed in real time and each is color coded. Automatic or Manual scaling can be used. The data is available for further analysis in a spreadsheet program.
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What type of assistance will Kaye provide for training?
Kaye has developed 1-, 2-, and 3-day training courses which are conducted in North Billerica, MA or at a customer site. (Click for more). Kaye personnel are also available for start up training from a regional office.
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Do you assist with the SOPs required for the new system?
Yes. A generic SOP has been written for customers to assist with operation of the new system. It is available in both hardcopy and as PC file.
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Is the Validator 2000 compatible with existing Kaye hardware?
Yes, with the IRTD-400, IRTD-500 Temperature Standards, HTR-400, LTR-140 Temperature Dry Wells, CTR-80 Temperature Bath
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Is the new system compatible with other Kaye software?
The hardware will not interface with other Kaye software. It is important to note that the unit will not utilize the current Windows 1.09 or DOS software.
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Is the Validator 2000 a replacement system for the Digi products?
Yes. The Validator 2000 uses current technology to provide ease-of-use and greater functionality to meet both internal and regulatory requirements. The new system is designed to meet FDA 21 CFR Part 11 regulations and Year 2000 requirements, as well as the operational time needs of today's validation departments. The benefits are also in the form of lower cost of service and upgrade.
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Will the system be available in different languages?
Yes. The Validator 2000 is available in German and will be available in French, Italian, Spanish, Japanese and Chinese during the third quarter of 2000.
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Will Kaye provide calibration data with the Validator 2000?
Yes. Kaye will provide a certificate of calibration for the instrument and the calibration SIM. (Click for more.)
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How can I disable the password function?
You can't. Implementing the FDA regulation 21 CFR Part 11 (more) requires at least two levels of password protection. To protect original data stored on electronic media, the new guidelines require this type of mechanism for security.
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Are there different types of password accounts?
Yes, there are three kinds of accounts:
- Administrator: has permission to create and maintain user accounts, set site options, and backup and restore user information.
- Supervisor: can create and modify Setup, calibrate sensors, run qualification studies and generate reports. A supervisor can also change system preferences if the Administrator has enabled the Allow Supervisors to change workstation defaults site option.
- Operator: uses prepared Setups to calibrate sensors, run qualification studies and generate reports. Operators cannot change Setups or system preferences.
For details, see the Help files in your software or refer to the User's Guide.
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Varied thermocouple readings during qualification study.
The cold junction compensation provided by a passive UTR (contained in any thermocouple measuring system) will always be sensitive to uneven heating. This is valid for the Digi family as well as the Validator 2000.
Avoid this condition by positioning the Validator in a location with stable and even temperature, not exposed to local heat sources, e.g. close to a sterilizer or near drafts. Temperature variations or exposure to external heat sources during calibration or qualification studies may cause temperature measurement errors.
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Error Message: SIM calibration data compromised.
This message appears when either the SIM with sensors has not been calibrated or is inserted in a Validator other than the one it was calibrated with. To correct this, connect your sensors to the SIM and run the first sensor calibration or insert the SIM in the Validator with the serial number identified on the screen. The first serial number will be the one where the SIM is currently inserted; the second will be the serial number of the Validator 2000 where the SIM was used to perform sensor calibration. Press Continue to acknowledge the message.
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Palm Pilot users: no PC communications with Validator hardware.
You cannot run software for a Palm Pilot and the Validator 2000 at the same time. Shut down the Pilot's application as it conflicts with the communications port required by the Validator
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