21 CFR Part 11 continues to cause confusion. Recent FDA guidance documents help, but many IT departments still struggle to establish appropriate validation processes with limited time and resources. Ecora's FREE in-depth guide, "Achieving Sustainable IT Compliance to 21 CFR Part 11," gives you an overview of the regulation from an IT perspective. It also outlines how you can accurately and cost-effectively implement a systems-based best practices approach that will help you meet FDA requirements.
Achieving Sustainable IT Compliance
to 21 CFR Part 11
In today's business climate, IT managers must demonstrate cost-effective, sustainable control of the IT infrastructure to ensure a company's profitability. With system complexity increasing exponentially, manually tracking configurations and changes is no longer an accurate, productive or cost-effective option. Easy-to-use and deploy, Ecora Change and Configuration Management solutions have helped over 3,500 companies worldwide do more with less by automating system configuration reporting and remediation across the enterprise. Based on best practice frameworks (ITIL, COSO, COBIT), Ecora solutions deliver operational efficiencies, maximum availability, and a greater level of security. Ecora's Change and Configuration Management Solution Suite: Ecora Auditor Professional is a powerful configuration and change reporting solution that collects over a million asset, security, and configuration settings from nearly every operating system, database management system, application, and network device found in an IT infrastructure. The configuration settings are stored in a centralized Configuration Management Database (CMDB) for on-demand, accurate auditing, reporting and change control. Ecora Auditor Professional eliminates the resource-intensive, error-prone manual process of managing enterprise-wide configurations and simplifies ongoing compliance with IT security standards and regulations. Ecora Auditor Professional includes a web-accessible executive dashboard providing at-a-glance validation of compliance to established IT controls, security policies, and configuration standards. The dashboard evaluates configuration information from the CMDB to generate an easy-to-understand pie graph displaying compliant and non-compliant systems as either green (compliant) or red (non-compliant). This enables IT managers to quickly identify non-compliant systems and direct the appropriate personnel to remediate any non-compliant configurations. Dozens of out-of-the-box report and policy templates are included for Sarbanes Oxley, HIPAA, GLBA, 21 CFR Part 11, VISA PCI, FISMA, and NIST IT requirements. You can also create your own reports and policies or customize existing ones. The Ecora Auditor Professional family also includes: Ecora Auditor Lite - A free application that collects and reports on hundreds of configuration settings from nearly every system and device in the IT infrastructure. The audit-ready documentation is generated on demand, and archived reports provide an easily accessible audit trail for effective disaster recovery, IT audits, troubleshooting, and consolidations. Ecora Auditor Basic - An upgrade from Auditor Lite that provides additional functionality by offering dozens of ready-made fact-finding report templates for quick, simplified analysis of critical configuration data such as access rights, NTFS permissions, and password settings. The Auditor product family supports VMware ESX servers; Microsoft Windows and Exchange servers, SQL Server databases, Active Directory, and workstations; HP-UX, AIX, Solaris, RedHat Linux, and Novell NetWare servers; Oracle databases, Citrix and IIS applications; Lotus Domino servers; and Cisco routers. For more information about Ecora solutions: www.ecora.com or 1.877.923.2672
Achieving Sustainable IT Compliance to 21 CFR Part 11 2 Achieving Sustainable IT Compliance to 21 CFR Part 11 Table of Contents TABLE OF CONTENTS ................................................................................................................................ 3 21 CFR Part 11 - An Overview ..................................................................................................4 Building Sustainable 21 CFR Part 11 Compliance...............................................................5 1997 -- Part 11 of Title 21 of the Code of Federal Regulations - Electronic Records; Electronic Signatures..................................................................................................6 2003 -- Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application................................................................................................................7 Change and Configuration Management: What it is and how it can help you gain control ...... [download for more]
