Paperless Recorders for Pharmaceutical Manufacturing Applications
DX100P/DX200P
Software
DAQSIGNIN
21 CFR Part 11 Compliance Application Software
DAQSIGNIN (standard accessory software package) allows you to display batch records and measured data along with operation logs and configuration data that have been stored on the DX100P/DX200P. Additionally electronic signatures can be added to the files, allowing for example quality control to sign records within a network environment at some time after the records have been completed.
Compatible with Windows 2000/XP/Vista (Home Premium or Business, excluding 64-bit version)
Data Management Software

Management Software
The data management software allows you to search for batch records by batch number, lot number etc, and review them using the viewer function. Whilst opening batch records the following data can be seen; batch number, lot number, file status, sign record status, measurement start and stop times, and the device ID. Also, you can perform a sort on the batch records by batch number, date, and other criteria.
Viewer Software

Electronics Signature/Operation Log
By entering the correct password or user ID/passwords, you can sign data files generated by the DX100P/DX200P that you have redisplayed or checked in trend, digital, circular, alarm table display, message table display, and other formats to an attached data file without changing the original data. If someone signed the file previously, you can confirm the signature status, check the comments, and then sign it yourself under your own log in.
Along with checking the configuration settings and operation log on the DX100P/DX200P, you can also make printouts for each batch record. Also, you can read in numerical values from the displayed data using the cursor, perform interval arithmetic, and convert files to ASCII, Excel, and Lotus 1-2-3 format.
Setting Software

You can display, edit, and save configuration settings related to the measurement and calculation channels, and settings related to the screen display and other items, and transfer them via the external medium to the DX100P/DX200P. Also, by opening several setting files, you can compare how the configuration changes were carried out, and obtain an audit trail.
You can also print out the configuration, and control them as paper documents.
