UVP Life Science - Manual (Page 260)

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Support 21 CFR Part 11 Compliance
Supporting 21 CFR Part 11 Compliance
• Purpose
• Features
• Usage
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 span the entire organization and its practices. The software supports
organizations with their 21 CFR Part 11 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) &endash; 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 ’r;History’ in the software.
• Section 11.3 (b) (4) &endash; 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 user name.
Usage
View an Image History Audit Trail
• 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.