How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

Product Id : FDA59
Instructor : Carolyn Troiano
Oct 09, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment.

The use of electronic records and signatures enables a company to conduct business in a paperless environment. However, this is only if the company adheres to the specific requirements put forth by FDA in their guidance for ER/ES. The paperless environment means that all signatures will be obtained through a software-enabled workflow system that routes the key documents to specifically approved signers. The workflow typically includes tracking of the status of the document, indicating where it is in the approval process. It also allows for signers to reject a document and request that either it be withdrawn altogether or modified in some manner.

The key to successful compliance of a paperless workflow and approval environment is setting up the right security and access rights, and authenticating signatures effectively.

Learning Objectives:

  • To learn how to interpret and apply the requirements set forth by FDA in 21 CFR Part 11, a guidance for electronic records and signatures (ER/ES)
  • To understand the implications of using ER/ES capability in the business process workflow
  • To learn how to evaluate the cost-benefit of using ER/ES capability in FDA-regulated systems
  • To understand how to mitigate any risks that emerge as a result of implementing ER/ES capability
  • To be able to prepare users for the changes in work processes that will be required in using ER/ES
  • To be able to identify and fill key roles and responsibilities required in the process of implementing ER/ES
  • To learn how to prepare a rationalization for the use of ER/ES to satisfy potential FDA audit questions
  • To learn how to work with FDA during an audit or discussion to ensure they are comfortable with the company's approach and methodology for implementing and supporting ER/ES capability
  • To learn by examples how some companies have implemented ER/ES capability and discuss the rationale behind it, cost-benefit analysis conducted, risk assessment conducted and some of the outcomes, both positive and negative

Session Highlight Points:

  • FDA's 21 CFR Part 11 guidance for electronic records and signatures
  • Pros and cons of implementing ER/ES capability
  • Cost-benefit analysis of implementing ER/ES capability
  • Risks associated with ER/ES implementation and potential mitigation
  • Organizational change management required to successfully implement and using ER/ES capability
  • Key roles and responsibilities required in the process of implementing, using and supporting systems with ER/ES capability
  • Key roles and responsibilities required in the process of implementing, using and supporting systems with ER/ES capability
  • Documenting ER/ES rationalization
  • Preparing for an FDA audit that will include scrutiny of applications with ER/ES capability
  • Examples of companies that have implemented ER/ES capability and discuss the rationale behind it, cost-benefit analysis conducted, risk assessment conducted and some of the outcomes, both successful and unsuccessful Compliance and Audit Managers

Who can Benefit:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).


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