FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures

Description

Description

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.

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. Rule 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).

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.

In this informative webinar our FDA expert speaker Carolyn Troiano will provide an overview of current industry trends which are related to ER/ES.

Topics Covered in this Session:

• 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))
• Validation Strategy
• System Risk Assessment
• GAMP 5 “V” Model
• 21 CFR Part 11 (FDA Guidance)
• Electronic Records/Electronic Signatures (ER/ES)
• Electronic System Workflow and Approval
• Security, Access, Change Control and Audit Trail
• Policies and Procedures
• Training and Organizational Change Management
• Industry Best Practices and Common Pitfalls

Who Will Benefit:

• Data “Owners”
• Data “Stewards”
• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Computer System Validation Specialists
• Business Stakeholders/Subject Matter Experts
• GMP Training Specialists
• Business System/Application Testers