21 CFR 11 Compliance

Explains WinWedge's role in Title 21 CFR Part 11 of the Code of Federal Regulations

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 us as it is often easier to explain in person or to answer specific questions.