Computer System Validation (CSV) for FDA-Regulated Computers
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system validation deliverables and how to document them through the entire process, also learn about what must be done to ensure the system remains in a validated state.
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA.
FDA’s guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements, and creating a set of test scripts that will prove each requirement is met.
This webinar will describe the approach to determining the level and robustness of testing required, based on a thorough risk assessment of the system, which includes the likelihood, severity, and detectability of potential failures of the system to work as expected, and the mitigation to be applied, should the system fail. Along with system categorization, in accordance with GAMP 5 principles, and an evaluation of the complexity and application of the software, the attendee will understand how to develop the rationale they will include in the validation plan for the level of testing executed.
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for validation, which will be discussed. We will also delve into the training requirements for users, testers, and those who will be the stewards of the system. All must be carefully documented.
Disaster Recovery and Business Continuity Planning will also be touched upon as key aspects of supporting the system in a validated state. Change control and periodic review will address the challenges of making certain that the system remains in control and is tested further according to any needs that arise from changes.
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.
Why should you Attend:
This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation (CSV), which is in accordance with the System Development Life Cycle (SDLC) Methodology. 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.
The SDLC will provide a framework for validation planning, allowing the attendee to understand all of the phases and deliverables required during validation. The end result will be a very well documented validation effort that will stand up to FDA scrutiny during an audit, and assure that the data housed and/or processed using the validated computer system will be maintained with great integrity.
It is important to remember that in addition to validating a computer system subject to FDA compliance, the system must be maintained in a validated state throughout its lifecycle, until the system is retired or otherwise no longer used. This webinar will describe the policies, procedures, training and other underlying support elements that are needed to ensure ongoing maintenance of a system in a validated state.
Areas Covered in the 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
- Electronic Records/Electronic Signatures (ER/ES)
- Security, Access, Change Control and Audit Trail
- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
Who Will Benefit:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Laboratory Managers
- Automation Analysts
- Manufacturing and Supply Chain Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
- Business System/Application Testers in FDA-Regulated Functional Areas
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.