Oprogramowania - 21 CFR Part 11

Mantech Inc.

21 CFR Product information:

21 CFR Letter 21CFR Letter

Software Screenshots

Password New Account Entry
  • Administrator defines new personnel who will have access to the PC-Titrate™ Software
  • Administrator also defines authority level which in turns defines access
  • Upon first entry, the user is prompted to enter a unique password
Password New Account Entry Screen Shot
Password Authority Levels
  • Administrator defines the authority levels, normally the hierarchy found within the laboratory
  • The authority levels are linked to the access which defines the software sections that can be accessed by each level
Password Authority Levels Screen Shot
Password Access
  • Administrator defines which menu options each authority level has access to
  • the menu options may be expanded to define access to sub-menu options
Password Access Screen Shot
Password Existing Account Edit
  • the administrator is able to change the status of account holders (users) within the system. For example, if a user leaves the lab, this user may be removed from the system
Password Existing Account Edit Screen Shot
Password Global Settings
  • the administrator defines how the password system works within the company
    • Options Iinclude:
    • Minimum character length for the password
    • Time for password expiration
    • Time for re-entry of the password if the system is left unattended (the PC-Titrate™ software automatically prompts for a password re-entry if interrupted during a run)
    • Number of times a password may be entered incorrectly before being disabled and more.
Password Global Settings Screen Shot
Audit Trail
  • "Making it easier for your auditor,   makes it easier for you!"

Audit Trail Explanation Window
  • with any change in any method, calibration, password, etc., an explanation window appears prompting the user to enter a reason for the change
  • this explanation is then viewed in the Audit Trail Report or the Audit Trail Review Screen
  • the user making the change has a digital signature linked to this change
Audit Trail Explanation Window Screen Shot
Audit Trail Review
  • view all versions of a specific method and quickly scroll through the reasons for any and all changes
  • link directly to the method to see full screen settings used at the time of analysis
  • print old and current version of the methods

Audit Trail Review Screen Shot
Audit Trail Report
  • with this report, quickly see changes from one method to the next
  • all changes are highlighted in "red" text for emphasis and ease of auditing
Audit Trail Report Screen Shot
Method Versioning
  • All methods, calibrations, schedules, etc. are versioned. For example, if a method is currently at version 10, this will be displayed as such, however, all previous versions can still be viewed
  • Methods, calibrations, schedules, etc., may be removed from use, but the records and their links to real analyses will remain within the database for auditing purposes

Data Security
  • The entire operating database may reside on a network system eliminating the need for file transfer
  • All reports (paper or electronic) are generated in real time from the secure database
  • With any network interruption, the system will automatically shut down with all results generated so far saved in the secure database