21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

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

Why Should You Attend:

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 in order 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.
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 their 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.

Areas Covered in the Webinar:

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

Who Will Benefit:

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.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

Information Technology Analysts
Information Technology Developers and Testers
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
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