Introduction
PerkinElmer’s UV WinLab™ Enhanced Security (ES) software platform for UV/Visible spectroscopy provides structural requirements and features to assist with the needs for ensuring data integrity and compliance. It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. The purpose of this document is to demonstrate how UV WinLab ES meets the technical requirements for 21 CFR Part 11.