Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment

Learning Objectives:-

• Learn the requirements for documenting efforts related to systems governed by FDA
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures.
• Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
• Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
• Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

Areas Covered:-

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• “GxP” – Good Manufacturing, Laboratory, and Clinical Practices
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Data Archival to ensure security, integrity, and compliance
• Data Integrity and Data Governance
• CSV Planning
• Functional Requirements Specification
• Design and Configuration Specifications
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Requirements Traceability Matrix (RTM)
• System Acceptance and Notification of Release
• System Maintenance
• Periodic Review
• Incident Reporting and Management
• Change Control
• Record and Data Retention
• System Retirement
• Q&A

Why Should you Attend:-

FDA requires that all computer systems that handle data regulated by the Agency be validated following their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed for the Agency to consider the documentation valid, and without following these, there is a great risk of invalidating work.

Who Should Attend:-

Manufacturing, Testing, Packaging, and Distribution companies in the following industries that are regulated by FDA are required to follow GPS:

• Pharmaceutical
• Medical Device
• Biologicals
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Personnel in the following roles will benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
• Auditors engaged in the internal inspection of labeling records and practices