Original can be described as the first capture of information, whether recorded on paper (static) or electronically (dynamic). Information that is captured in a dynamic state should remain available in that state. (Note: I recommend reading Tip 411 before reading this tip)
Let’s see how it’s done!
Things to consider:
Set Result Sign Off Policies for electronic signatures:
Prevent anyone from signing off on Results with someone else’s credentials
Lock Channels after Sign Off 2, preventing further processing
Enforce workflow by requiring Sign Off 1 before Sign Off 2
Store a PDF copy for each sign off
Set User Privileges:
Using electronic signatures requires Users to review data within Empower and promotes electronic review of the original records
Two levels of sign off allows segregation of duties, i.e., one level to create/peer review data and one level to approve/reject results
This leads to effective data review using View Filters and Exception Reporting
Audit Trails:
Audit Trails are considered part of the original record for review
Project Audit Trail tracks all activity within the project
Use Result Audit Viewer to review audit trail records related to Result Set generated
It’s that easy!
Note: System Policies and User Privileges are set in Configuration Manager.
Neil provides internal support for Empower CDS software and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives.
Need Help? Connect with a Waters expert.