21 CFR Part 11, FDA Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

The Webinar will ensure that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach, incorporating it into the overall computer system validation program, and plans for individual systems with this capability.

• Understand what constitutes an electronic record and an electronic signature.
• Learn about the FDA requirements for handling electronic records and electronic signatures using a computer system regulated by the FDA.
• Learn about the FDA’s current thinking about technology and software development, and how this will impact the industry.
• Learn about FDA’s current trends in compliance and enforcement related to 21 CFR Part 11.
• Learn how to apply a consistent approach to validation for FDA-regulated computer systems.
• Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements.
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation.
• Learn about cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively.
• Understand the best practices for documenting computer system validation efforts, whether using a Waterfall or Agile approach, including requirements, design, development, testing, and operational maintenance procedures, including ways to improve the efficiency and effectiveness of managing related documentation.
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach.
• Learn how to ensure the integrity of data that supports GxP work, despite changes and advances in new technology.
• Gain deep knowledge about the “ALCOA+” acronym for data integrity to ensure it is attributable, legible, contemporaneous, original or “true copy,” and accurate, plus available, enduring, complete, and consistent.
• Understand the importance of “GxP” documentation that complies with FDA requirements.
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state, with a focus on electronic records/signatures.
• Know the regulatory influences that lead to the FDA’s current thinking at any given time.
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance for computer systems using electronic record and electronic signature capability, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle.

This webinar will cover the following key areas:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Data Integrity (DI)
• Validation Strategy, Planning and Execution
• System Risk Assessment
• GAMP 5 “V” Model and Software Categorization
• 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
• Security, Access, Change Control, and Audit Trail
• Criteria required to ensure data is created and maintained with integrity through its life cycle
• Policies and Procedures to support CSV and DI assurance
• Training and Organizational Change Management
• Current FDA Trends in Compliance and Enforcement
• Industry Best Practices and Common Pitfalls
• Q&A

FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. 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. Rules for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also 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 the 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 help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it. 

This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance.