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LABEL MATRIX
  ¿Qué pasos puedo tomar para asegurar que LABEL MATRIX PowerPro cumple con 21 CFR Par 11?
  Siga estos tres pasos sencillos para configurar LABEL MATRIX PowePro para que cumpla con los requisitos:

Paso I – Configurar acceso seguro para diseño de etiqueta
Paso II – Seguridad para variables de datos
Paso III – Escribir datos a un archivo


Step I – Set up secured access for label design

Global Security
  1. Choose Setup from the Tools menu.
  2. Click the Passwords tab.



  3. Click Add to set up the first user account. The first user to set up a password is automatically granted administration privileges, meaning that this person is the only user allowed to add and modify user accounts.



  4. Enter a User Name and Password for the first user (the administrator) and click OK.



  5. Click Add again to add another user.



  6. Enter a User Name and Password, and click the appropriate Access check boxes to set up access privileges for this user.



  7. Continue to add as many users as necessary.




Label Specific Security
  1. Choose Label Properties from the File menu.
  2. Click the Security tab.



  3. Click the Enable Design Security check box.
  4. Enter and confirm a password to set up security on the active label design file.
  5. If you want to require users to enter the password in order to print this label, click the Require Design Password To Print check box.


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Step II – Security for Variable Data

Clear values from Previous Print Jobs
  1. Create a Counter or Keyboard Input field.
  2. On the Data tab, click the Advanced button to access the advanced properties.



  3. Set the Keep Changes option to No.


This will ensure that users must enter/select the variable data before each print job (the value entered for the last print job will NOT be saved).

Double Entry Verification
  1. Create a Keyboard Input field.
  2. On the Data tab, click the Advanced button to access the advanced properties.



  3. Click the Double Entry Verification check box.



    With this option enabled, at print time the user is prompted to enter the data and then prompted again to enter the data a second time to verify that the data was entered correctly. If both values do not match the user will not be allowed to proceed with the print job.


Variable Data Filter
  1. Create a Keyboard Input field.
  2. On the Data tab, click the Advanced button to access the advanced properties.



  3. Click the Filter drop-down list and select the appropriate filter set. The filter set specifies the type of data that must be entered for this Keyboard Input prompt at print time. For example, you could set up this keyboard prompt to accept only numeric data.


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Step III – Write data to a file

  1. Choose Label Properties from the File menu.
  2. Click the Write Data tab.



  3. Click the appropriate check boxes on this tab to write image data (data as it appears on the label) and/or variable data to a comma-delimited text file (.TXT extension). This allows you to keep a record of all label information that is printed.


TEKLYNX software assists companies and its investigators in complying with 21 CFR Part 11. Using proper design techniques and tools can make compliance easier. This document is intended to make it easier for you to comply with any future FDA regulations on discovery using LABEL MATRIX.
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