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

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 It also allows for signers to reject a document and request that either it be withdrawn altogether or modified in some manner.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.

Why You Should Attend:

The attendees will learn how to develop a standard approach to establishing and maintaining the use of ER/ES to handle records and approvals in an FDA regulated environment. There are specific best practices that should be considered before choosing to implement these capabilities and operate in a “paperless” environment, and these will be discussed. We will discuss the pros and cons for using ER/ES, and talk about the ramifications of choosing to do so. The attendee will be prepared to make a determination about applying ER/ES capabilities in their workplace, and will be able to implement the best practices for maintaining ER/ES in a compliant manner.

We will touch on those areas that are critical to meeting the requirements set forth in FDA’s 21 CFR Part 11, including security and newer technologies that are emerging for capturing, analyzing, storing and reporting information for decision-making purposes.

It’s important to look at what are some of the threats and challenges of using ER/ES, and what methods you can use to mitigate these. Similarly, it is important to identify opportunities that might help companies decrease the cost of compliance and improve operational efficiencies and effectiveness through the use of ER/ES.

Areas Covered in the Session :

• 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
• System Development Life Cycle (SDLC) approach to validation
• 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
• Integration of ER/ES capability in existing applications
• 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 Will Benefit:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.