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 It also allows for signers to reject a document and request that either it be withdrawn altogether or modified in some manner.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.
The attendee 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.
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.