DatabaseAdministrator(SCMSDA).PDF

Agilent Cary WinUV Software with Spectroscopy Confi guration Manager and Spectroscopy Database Administrator (SCM/SDA) Compliance with 21 CFR Part 11 Introduction Part 11 in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting electronic records and applying electronic signatures. The intent of these guidelines is to ensure that applicable electronic records are reliable, authentic and maintained with high integrity. This technical note describes features and functionality of Agilent Cary WinUV (version 4.X and later) in combination with SCM and SDA for data management and electronic traceability, which enable customers to implement the guidelines of 21 CFR Part 11. This document examines each section of 21 CFR Part 11 and provides a recommended approach using the Agilent Cary WinUV, the application software, with SCM/SDA (version 3.1 or higher). This solution provides the necessary controls for system access, user roles management, data transfer and audit trails. It also ensures secure record keeping and provides capabilities for data archiving. Agilent Cary WinUV with SCM/SDA: 21 CFR Part 11 Compliance Using Agilent Cary WinUV with SCM/SDA provides support for all compliance requirements mandated by 21 CFR Part 11 for a closed system. In particular it ensures: • Accurate and complete copies of records, • Administration for user accounts and passwords, • Administration for user access privileges within the application, • Mandatory login to SCM before allowing access to Cary WinUV, • Electronic signature functionality, and • Records of changes captured in user-independent time-stamped audit trails These settings can be confi gured during installation to meet specifi c standard operation procedures and security guidelines. This includes customizable user roles and privileges that provide levels of access to the application software and functionality to individual user