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DAQSTATION Pharmaceutical Models

DX100P/DX200P
Functions
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Complies with Electronic Recording Regulation (21 CFR Part 11)
  ASCII and Binary Data Display

ASCII Data Display
Binary Data Display

The DX100P/DX200P saves measured data, measured settings, and the operation log into one, binary file.
Binary data is tamper proof, offering a high level of security.
DX100P/DX200P and the PC software can provide an alarm if the file is damaged or altered in any way.

  Batch Name Input Screen
Batch Name Input Screen

A batch name (batch number + lot number) can be assigned in operation mode which is accessible to users with appropriate access rights. It is possible to configure automatic incrementing of lot numbers at the start of each batch if necessary. Assigning batch names provides a reference that you can use to retrieve historical measurement data.
You can also store comments related to the measured data along with 3 lines of User information.

  User ID and Password Input Screen
User ID and Password Input Screen

Administrators can assign up to 90 user names in the system mode, and by configuring log in modes, can specify which functions are available to each user, as well as limiting the number of people operating the DX100P/DX200P. With log in mode settings the recorder operation can be determined on a user by user basis.

  Log In History Screen
Log In History Screen

The configuration of the DX100P/DX200P cannot be changed whilst the DX100P/DX200P is storing data. Configuration changes made are automatically stored to the recorder media once any changes have been completed.

  Sign Record
Sign Record

After a batch is complete it is displayed in the DX100P/DX200P’s historical display mode, or by use of the associated PC software. After checking the historical data ,it is possible to sign the batch record. Information concerning the batch review such as, Pass/Fail determination and comments, can be added as the record is signed. Three levels of signature are possible such as operator level, supervisor level, and quality control level. The original data is in no way affected. Signing a record involves inputting a password, or user ID and password. With the sign record function, you no longer need paper copies for document control.

  Password Renewal
Password Renewal

A user name and password, or user name, user ID, and password are necessary to log in. The DX100P/DX200P checks each user name against previous user IDs and passwords, and prevents duplicate password registration. Additionally the DX100P/DX200P checks for duplicate user names.
Also, with the automatic password expiration function, persons attempting to log in with passwords exceeding previously entered expiration dates will be prompted to have their passwords renewed.

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