Software in 21CFR11 Environments

 

The Micromeritics Confirm applications for 21CFR11 environments require an operating system of Windows 10 Professional or Windows 10 Enterprise or higher. Management of users and groups is performed in Windows Users and Groups.

The Micromeritics Confirm application enables laboratory managers to develop analysis methods, enforce industry standards, and produce audit trails. It also enables laboratory analysts to perform analyses and produce reports.

User Permissions

Confirm User Name Description
mic_confirm_user

mic_confirm_user is the user name used by all installations.

  • This user should have complete control over the installation directory.
  • The application is launched under this user name and has this user’s privileges to the windows file system.
  • This user should not be used by anyone or any other software that is not a Micromeritics application.
  • The system administrator has the option of modifying this account so that the password never expires. Alternatively, if the password does expire while the application is running, the application automatically changes the password for this account.
Confirm Group Name Description
Developer Group

The default Developer group name is
mic_[analyzer model number]_developer
. Members of the Developer group:

  • have rights to all functions of the Micromeritics application - including Advanced option presentation which allows the creation and modification of methods, sample files, and parameter files.
  • can run an analysis.
  • can also be assigned Administrator rights which control the user profiles.
Analyst Group

The default Analyst group name is
mic_[analyzer model number]_analyst
. Members of the Analyst group:

  • have access to the Basic presentation option only.
  • may create sample files from pre-defined methods and can modify only a limited number of input fields.

Option Presentation for 21CFR11 Environments

Option Presentation Display
Presentation Display Description
Advanced Displays all parts of sample and parameter files. Navigate to parameter windows by selecting the tabs across the top of the window.
Basic Displays sample information in a single window. This display option is used after the parameter files have been created. The previously entered or default parameter files are then accessible using drop-down lists.
Restricted Displays the sample file in a single window similar to the Basic display option with certain functions disabled. A password is set when the Restricted option is selected. That same password must be entered to change to the Basic or Advanced display option. This display type is typically used in laboratories where analysis conditions must remain constant — such as the pharmaceutical industry. The Advanced option is not available in the view selector at the bottom of the window when using the Restricted display option.
Always Open Edit View Opens files with a Complete status in tabbed file editor rather than in the Peak Editor view.
Show Splash Screen Enables (or disables) the splash screen upon application startup.
Show Cup Properties Enable to show the cup properties for a pycnometer analyzer.
Show Asphalt Options Enable to show the asphalt properties for a pycnometer analyzer.
 

For members of the Developer group only. To change the view from Advanced (for Developers) to Basic (for Analysts), click the view selector drop-down list at the bottom of the window. Select either Advanced  (when in Basic view) or Basic  (when in Advanced view).

The following examples show the same sample file in Advanced and Basic display.

  A sample file must be created for each analysis. The file can be created prior to or at the time of analysis. The sample file identifies the sample, guides the analysis, and specifies report options.

The Save button is disabled on sample files with a Complete status. When the Preview button is used to view reports for sample files with an unsaved status, the report will have a Preview watermark. The Save As and Print buttons on the report window are also disabled.

Create a New Folder

Provides the option to create and name a new folder in the Confirm application folder. This option may not be available depending on how the IT administrator configures Windows permissions.

System Audit Trail

Lists the current user, successful and failed application user login attempts, and contains a description of all the changes made to sample files.

Contains an audit trail of all system initializations, user login attempts, and sample analyses.

 
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