PDF-Guidance for Industry Part Electronic Records Electronic Signatures Scope and Application

Author : tatiana-dople | Published Date : 2014-12-01

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologi cs Evaluation and Research

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document "Guidance for Industry Part Electronic R..." is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Guidance for Industry Part Electronic Records Electronic Signatures Scope and Application: Transcript

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologi cs Evaluation and Research CBER Center for Devices and Radiological Health CDRH Center for Food Safety and Applied. Electronic Signature Solutions. 11/10/. 2015. Agenda. Methodology, Framework & Approach: High-Level. Overarching Parameters Regarding Electronic Service Delivery. Business Analysis & Risk Assessment Are Required. Slides by Kent Seamons and Tim van . der. Horst. Last Updated: Oct . 7. , 2013. Digital Signatures. Diagram illustrating how to sign a message. Why do we use a one-way hash?. How does a collision or second pre-image attack relate to this?. Donna Read, CRM, CDIA+. Florida Gulf Coast ARMA Chapter. October 2015. AGENDA. Where we stand now. How did we get here. Is it working for you?. What does it take to fix it. Current Situation. Decentralized control of records & information. Stanford University. Finding Similar . Items. Shingling. Minhashing. Locality-Sensitive Hashing. Administrivia. Wednesday, January 13. Computer Forum Career Fair. 11am - 4pm. Lawn between the Gates and Packard . Masayuki Abe, NTT. Jens Groth, University College London. Kristiyan. . Haralambiev. , NYU. Miyako. Ohkubo, NICT. Mathematical structures in cryptography. Cyclic prime order group . G. Useful mathematical structure. AGENDA. 21 CFR Part 11. . Sections in 21 CFR Part 11. Terminology. About Part 11. Importance of Part 11. Scope of Part 11. Applications. Advantages. Validation. Predicate rule requirements. Security Procedures. . Sections in 21 CFR Part 11. Terminology. About Part 11. Importance of Part 11. Scope of Part 11. Applications. Advantages. Validation. Predicate rule requirements. Security Procedures. Qualification &Accountability. Electronic Records Management. Session 5 of 7 on records management. Session Guidelines . and general information. Presenter(s). Karen . Gray. Records Analyst. (Records Retention Schedules and Imaging – State Agencies. Charles Yan, PhD. Senior Director, Clinical Data Management. Jiangsu . Hengrui. Pharmaceutical Co. LTD. Topics. What is Part 11. Background. Scope and Component . R. equirements. FDA 21CFR11 . Inspection . By . Group 5 members:. Kinal. . Patel. David A. . Ronca. Tolulope. . Oke. CONTENT. BACKGROUND . RISKS . CONTROLS. Definition. “An . electronic medical record. (EMR) is a digital version of a paper chart that contains all of a patient's . Theodore J. Hull. Archivist. Electronic Records Archival Services. National Archives and Records Administration. A presentation for the Annual Meeting of the Society of American Archivists. August 2011. and FDA Staff Class II Special Controls Guidance Document Surgical Sutures Guidance for Industry and FDA Document issued on June 3 2003 This document supersedes 147Class II Special Controls Guidance FDIC Consumer Compliance Examination Manual January201The Electronic Signatures in Global and National Commerce Act ESign ActIntroductionThe Electronic Signatures in Global and National Commerce ActSi What Students Will Do:. Discuss requirements with clinical collaborator. – Design solution. – Fabricate solution. – Test solution in simple model. – Redesign until satisfactory. Deliverables:.

Download Document

Here is the link to download the presentation.
"Guidance for Industry Part Electronic Records Electronic Signatures Scope and Application"The content belongs to its owner. You may download and print it for personal use, without modification, and keep all copyright notices. By downloading, you agree to these terms.