This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
What participants will learn:
Why Should You Attend:
It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes. This seminar will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.What participants will learn:
- US FDA and EU requirements for change control
- Defining configuration management versus change control and change management
- The IEEE model for configuration management and change control
- Reviewing a change control procedure
- Change control for hardware, operating systems, and application software
- The change control process for planned and unplanned changes
- Versioning of software and computer systems
- What to test after changes
- How to document changes
- Learning through examples
- Computer hardware, firmware
- Software (operating system, applications, security patches)
- Networks (server, client, router)
- Documentation (specifications)
- Who Should Attend:
- Everybody involved in software and computer system validation
- IT Administrators
- QA managers and personnel
- Validation specialists
- Suppliers of software and computer systems
- Regulatory affairs
- Training department
- Consultants
Course Provider
Dr. Ludwig Huber,
