UVP Doc-It Life Science - Manual (Page 108)

Supporting 21 CFR Part 11 Compliance
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Supporting 21 CFR Part 11 Compliance
Purpose
US - Food and Drug Administration (US-FDA) created and released Part 11 of Title 21 of Code of Federal
Regulations (CFR) in August 1997.
The rules delineate the conditions under which the US-FDA considers electronic records and electronic
signatures equivalent to paper records and paper signatures. The instructions for compliance really span
the entire organization and its practices. The Software by UVP is one piece that rightly fits into the bigger
picture and supports compliance.
NOTE: While software from UVP, LLC is an essential tool for assisting an organization to
maintain CFR compliance, UVP cannot claim that this is the only tool needed to achieve overall
CFR compliance. The organization must establish policies and procedures that work in
conjunction with such efficient tools, to ensure total compliance with 21 CFR Part 11
regulations.
Features
UVP provides software support for the following two sections of CFR regulations:
Section 11.10 (e) – For electronic records, this section requires the use of computer- generated,
time-stamped audit-trails to track changes.
The software keeps track of all changes that affect image-data. Any action in the software that
modifies the original data of an image open in the LS workspace, is logged. The log of such
changes is individually maintained for each image and is referred to as History in the software.
Section 11.3 (b) (4) – This section mandates that the system be controlled by users responsible
overall for contents of electronic records required to track.
The software provides an elaborate system of maintaining secure user accounts. Assign unique
usernames and passwords to all the users who will be using the software. Each account can also be
configured to provide read or modify access to other users data. Events generated in the audit trail
(above) are logged with the username.
Usage
Viewing an Audit Trail (History)
Open the image in question.
Right click on the image and select Image Information. Open the History tab.
Events are listed in the left column. Click on each event to view the entry details on the
right.
Add notes to each event if required.
Printing an Audit Trail (History)
Open the image for which to print the Audit Trail.
Go to Tools > Reports. (This option is disabled, if no printer is available.) A window