FDA Compliance - CFR Part 11

Description

This article details the issues regarding FDA Compliance - CFR Part 11, specifically the following.

• Secured access to the software for design
• Print only what is entered in the template
• Save printed data
• Security
  

Solution

Secured Access

1. Choose Preferences > Security from the Options menu in either Loftware Design Mode or On-Demand Print.
2. Check the appropriate boxes to enable LLM's Security features.
3. Enter a Password.

Print Entered / Retreived Data Only

1. Choose Preferences from the Options menu in either Loftware Design Mode or in On Demand Print.
2. Choose All Print Modules and make sure the Allow printing if record not found is unchecked.
3. Choose On-Demand Print, check Clear Database Key field if Record Not Found and Clear Database Key Field and Data Fields After Successful Printing.

Save Printed Data

1. From the Options menu in either Loftware Design Mode or On-Demand Print, chooseEnable Auditing.
2. To configure the data that is saved, in either Loftware Design Mode or in On-Demand Print, choose Preferences > Reports
3. From Options menu, choose Audit File Reports and check the appropriate boxes or change delimiter and extension as necessary.

Note: Files are saved on a daily basis in the Loftware Labeling | Audit sub-directory and may be opened or imported into several packages including Access, Excel, Notepad, Word, etc.

Security

Access to most applications is controlled through User Permissions via standard Microsoft settings based on User profile. Sharing and Permissions settings are also available for Windows Terminal Server, Citrix, and Loftware's Thin Client for On-Demand Print (which excludes access to Design as there are no applications running on the PC or Terminal. ..fmi contact your Network Administrator.)
For more information visit the FDA's Website or Part 11 Website. Links verified 6-23-09.