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21 CFR Part II Compliance0 pages
21 CFR PART 11
PRODIGY DELIVERS THE COMPLIANCE TOOLS YOU NEED
In 1997, the FDA issued regulations originally designed to qualify the electronic submission of data.
These regulations were designed to provide criteria for acceptance of electronic records as equivalent to
paper records. Since that time the scope of the regulation has expanded to include most instruments that
can maintain an electronic record of results. Similarly, the EPA has introduced CHROMERR (Cross-
Media Electronic Reporting and Record keeping Rule) into environmental analyses.
Login
User Login Administration
Add Users—
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Authorizedpersonnel (other than the system administrator) may access the "User Login
Administration" panel only to change their password.
21 CFR part 11 requires that the
instruments employed be able to track
the active operators, control their access
to sensitive operations and record their
activities at the instrument.
Prodigy satisfies this requirement by
demanding the active operators log into the
software with a valid password before any
further action is permitted.
Further, the system administrator alone has
the authority to add new users, de-activate
obsolete users, and assign specified user
permission levels.
The log-in icon is available at all
times after successful login and allows
easy transition between active operators.
Audit Trail
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Recent changes are identified with asterisks for easy recognition.
All actions and instrument conditions
must be recorded in an audit trail.
Prodigy offers an audit trail sorted by
method.
• Once a method name is selected, all of
the analyses for that method appear
chronologically.
• Highlighting an analysis block (see
highlight to left) displays a snapshot
of all of the method parameters active
at that time.
• Subsequently, selecting an analytical
line reveals all of the information for
the data acquired at that line.
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