Title 21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Any organization with regulated applications that fall under the Title 21 CFR Part 11 need to ensure that any changes and access to these regulated applications have been conducted through a rigorous and auditable process. The Micro Focus e-Signature solution for Application Lifecycle Management (ALM) drives a paperless yet full traceable and auditable process where Micro Focus ALM entities can be electronically signed post every human interaction, rejection or approval. Micro Focus e-Signature runs on either ALM Octane or ALM/Quality Center enabling e-Signature through the application lifecycle in requirements, backlogs, defects, tests, test plans, execution and pipelines. This QuickStart ALM/Quality Center project provides you with all capabilities only for Defects control. A full comprehensive solution offering the e-Signature solution for ALM/Quality Center or ALM Octane is available through Micro Focus Professional Services .
The QuickStart project and software are provided as a courtesy, free of charge, "AS-IS" by EntIT Software LLC ("Micro Focus"). Micro Focus shall have no obligation to maintain or support this software. Micro Focus MAKES NO EXPRESS OR IMPLIED WARRANTY OF ANY KIND REGARDING THIS SOFTWARE. Micro Focus SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY, IN CONNECTION WITH OR ARISING OUT OF THE FURNISHING, PERFORMANCE OR USE OF THIS SOFTWARE
For more information Contact your representative or email Professionals Services at firstname.lastname@example.org Learn more at: https://software.microfocus.com/en-us/software/alm-consulting-services Read our E-Signature for ALM Flyer.
This is a sample implementation of E-Signature for ALM for the Defect entity based in ALM/Quality Center. E-Signature for ALM Features Here is a brief features list: E-signature capabilities for status changes A customizable number of approval stages Full flexibility by leveraging ALM/Quality Center customization Minimal dependencies The required UI components are provided by a custom dll which is also available for downloading. Please follow installation instructions provided at the Help file. In the bundle also find a FAQ (Frequently Asked Questions) document for most common questions and answers.
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The QuickStart project has been updated for ALM/QC 15.x.
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