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Press Release

 
     
WinWedge and 21 CFR 11 Compliance  
 

Feb 2005

 
 

WinWedge collects data directly from any laboratory instrument into any Windows application - Excel, Access, LIMS, etc. It can be used to easily collect data from balances, meters, analyzers, gauges, sensors, counters, GPS, etc.

For 21 CFR 11 compliance data from all instruments needs to be tracked with other information such as the person performing the experiment, date and time, etc. The information always needs to accompany the measurement data and be stored with it in the database or LIMS. WinWedge is not data “storage” software. It transmits the data from the instruments to other applications (i.e. Excel, Access, LIMS) for storage and analysis so it is very important that these applications are set up to be 21 CRF 11 compliant (most LIMS are). This means they must be able to store and track the additional fields with the measurement data.

The data that WinWedge transmits also needs to contain the additional fields of information, such as the user and date and time, as well as the instrument data. Some new instruments can be configured to send this information automatically with the instrument data and WinWedge will keep the additional information with the data and transmit it to the required fields in your application program. If, however, you have an older instrument then you will need to set WinWedge up to add identifiers to your data to make your instrument data 21 CFR 11 compliant. These identifiers could be a person's name and/or special characters that you select. WinWedge can also add date and time stamps to your data before transmitting it to your other 21 CRF 11 compliant databases, spreadsheet and LIMS.

I hope this makes sense to you. If you still have questions please call me at 800-722-6004 x 103 as it is often easier to explain in person or to answer specific questions.

WinWedge is $259 for the standard and $495 for the Pro versions. Both versions can add identifiers to the device data but the Pro version has more data parsing, filtering and formatting options. We can also provide Software Validation Reports for the Pro version. These are required by the FDA in certain industries.

 
     
     
   CONTACT INFORMATION  
 
 
 

TAL Technologies Inc, 2101 Brandywine Street, Suite 102, Philadelphia, PA 19130, USA.
215-496-0222 or 800-722-6004 (USA only). Fax: 215-496-0322.

Contact: Susan Rogers, VP Marketing, Tel: 215-496-0222 or
e-mail:

 

 
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