21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result.

A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval). A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets its responsibility for meeting it.

As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Upon completion of this session, attendees will have an understanding of how to:

• The activities and investments to support corporate drivers, strategies, and compliance
• Establish 21 CFR Part 11 program compliance, including objectives, decision-making organizational structures, and assigned roles and responsibilities that fit within the organizational culture
• Understand the role of data owners vs. data stewards
• Understand the criticality of data identity, trust, security, integrity, accessibility, reliability, and consistency
• Design data governance processes that encompass people, processes, and technology
• Understand the policies and procedures necessary to support the data governance framework

• Learn about 21 CFR Part 11 and what is required for compliance
• Learn about industry best practices related to compliance and computer system validation
• Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
• Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to gain information about trends in validation, as the industry progresses and new best practices emerge
• Understand some of the industry best practices and FDA inspection trends that will help you to achieve 21 CFR Part 11 Compliance
• Q&A

You should attend this seminar if you are responsible for planning, executing, or managing the implementation of any system governed by FDA regulations that use ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be overwhelming.  This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Manufacturing Supervisors and other Key Personnel
• Warehouse and Supply Chain Supervisors and Other Key Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Clinical Data Managers and Scientists
• Quality Managers, Chemists, and Microbiologists
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries

Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of products must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.

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.