H&A Scientific, Inc.

Frequently Asked Questions

Q: What versions of the SLIM software are currently available?
A: SQL Server Version, SLIM Client Version 2.12.1 (Free to all registered users), SLIM Server Version 3.4.0 (Free to all registered users)
Oracle Version, SLIM Client Version 2.11.1 (Free to all registered users), SLIM Server Version 3.4.0 (Free to all registered users)

Q: What additional User Acceptance testing services are available from H&A Scientific, Inc.?
A: We also offer a User Acceptance Validation Service: SLIM (and SLIMStat+) have been validated at H&A Scientific, Inc. However, if you require on-site user acceptance testing, we have prepared User Requirements Specifications. You may edit this User Requirements Specifications specifically for your company. We supply mapping documents that map requirements to test cases, which we supply in the form of User Acceptance Testing documents. Finally, we assist in the preparation of a conclusion document. The above package can be executed by your company, an outside consultant of your choice, or we can execute the testing.

Q: What is the current release version?
A: Version 4.2.0 has been released. Changes are documented in document REL-04-001 "SLIMStat and SLIMStat+ Release Notes." This document is free to all registered users.

Q: Where is a reference to the SLIMStat calculations?
A: We have documented the formulas in the SLIMStat manual. For Room Temperature dating refer to chapter 21A, Stability of Drugs, Room Temperature Tests, by Karl K. Lin, Tsae-Yun D. Lin, and Roswitha E. Kelly, in the book Statistics in the Pharmaceutical Industry, second edition, edited by C. Ralph Buncher and Jia-Yeong Tsay, Marcel Dekker, Inc., New York. For Accelerated dating refer to chapter 9, Accelerated Testing, by Shein-Chung Chow and Jen-Pei Liu, in the book Statistical Design and Analysis in Pharmaceutical Science, Marcel Dekker, Inc., New York.

Q: Is SLIMStat a general purpose statistical program?
A: SLIMStat is written specifically to calculate shelf life (expiry dating) and not to be a general purpose statistical program. That's why it is so easy to use. You simply enter the test results (or use SLIM to send the test results from the database) and the product's shelf life is automatically generated.

Q: What parameters can be varied?
A: The confidence interval can be set at upper, upper and lower, or lower. The P-value may be set at 0.25, 0.10, or 0.05. The probability level is preset to 95% as required by the FDA.

Q: How does SLIMStat treat less than (<) values, e.g., if a degradation product is less than the limit of detection?
A: SLIMStat gives the user four options, easily selected by clicking a radio button:
1. Ignore. The value will not be used in any calculations.
2. Value. The < sign will be ignored and the value will be used verbatim.
3. Value divided by two. The value will be divided by 2.0 and the result used.
4. Zero. The value will be replaced by zero.

Q: Does SLIMStat require the user to purchase any other programs?
A: No. SLIMStat is a standalone application. It will automatically accept data from SLIM, however. It will also accept data from ASCII files, the clipboard, and the keyboard. It can also export data to other programs.

Q: Can ChromWave be used in the validation of A/D interfaces?
A: Yes. ChromWave may be an integral part of the validation program within your laboratory.

Q: How is ChromWave calibrated?
A: Not with a screwdriver (by design!). We do not use any potentiometers that may drift with time. We use a process of software calibration. The ChromWave hardware is placed inside a Faraday cage to minimize electromagnetic interference. The temperature and humidity are monitored using a NIST traceable thermometer and digital hygrometer. Each of the ChromWave waveforms at each of the voltage ranges is output to a NIST traceable digital voltmeter. The digitized voltage readings are then transferred via a HP-IB connection to the host computer. This data is properly formatted into a calibration file. Thus, each ChromWave device will have a unique calibration file.

Q: How often should ChromWave be recertified?
A: We recertify our NIST traceable digital voltmeter twice a year. It is currently recommended that ChromWave be recertified once a year.

Q: Will ChromWave work with strip chart recorders?
A: Yes. ChromWave was primarily designed for chromatographic workstations, but you may connect ChromWave hardware to a strip chart recorder and record the waveforms on your strip chart recorder. The LINEARITY and REPRODUCIBILITY waveforms will be very informative. Simply measure the strip chart recorder peak heights with your pencil and ruler, and compare them with the KEY peak heights.