Computerized Systems Validation (CSV) Seminar
In this Computerized Systems Validation (CSV) seminar, you will learn how to validate your computer software quickly and in compliance with the requirements of ISO 13485:2016 and 21 CFR part 820.
This one-day seminar on computer systems validation will focus on the following learning objectives:
- Regulatory requirements
You will learn about the regulatory requirements for validating computerized systems, in particular the requirements of ISO 13485:2016, 21 CFR part 820 and part 11.
You will be able to decide which systems require validation and which changes lead to re-validation. You will become aware of the typical issues that arise during CSV audits.
- Best Practices
After the seminar, you will know which best practice guides (e.g., AAMI TIR 36, IEC 80002-2, GAMP) can help you in validating your software systems, and you will understand the interactions of computerized systems validation and IQ, OQ, and PQ.
- Risk Management
You will understand how risk management drives the CSV effort and how to minimize effort for non-critical systems.
- Validation Plan
After this one-day training, you will know what aspects to address in the validation plan and you will be able to assess how effort and complexity of the CSV are affected by system size as well as software/process risk estimation. You will be able to detect and correct flaws in a validation plan.
- Validation and documentation
You will learn about important approaches for testing and validation such as black box testing methods. After this one-day training, you will understand, which roles should execute which validation tasks, and how to establish lean documentation of validation results.
|Time ||Topic |
|9:00 AM ||Start of seminar |
|9:00 AM ||Expectations |
|9:15 AM ||Introduction, definition of terms (incl. IQ, OQ, PQ), examples of systems, overview of process |
|10:00 AM ||Regulatory requirements for CSV |
|10:30 AM ||Break |
|10:45 AM ||Determine intended purpose, process and software requirements |
|11:15 AM ||Analyze risks, classify systems, determine scope of validation |
|12:00 PM ||Summary, recap, Q&A |
|12:15 PM ||Lunch |
|1:15 PM ||Selecting test methods and tools |
|2:00 PM ||Creating a validation plan and test specification |
|2:45 PM ||Break |
|3:00 PM ||Performing and documenting validation, Good Documentation Practice (GDP) |
|3:30 PM ||Changing systems, deciding on re-validation |
|3:45 PM ||Roles and responsibilities, procedural instructions for CSV |
|4:15 PM ||Overview of best practice guides e.g., AAMI TIR 36, IEC 80002-2, GAMP |
|5:00 PM ||Summary, recap, Q&A session |
|5:15 PM ||End of seminar |
This seminar on Computerized System Validation is aimed at the following groups in particular:
- Quality Manager
- Process owners
- (Software) Developers and software testers
- IT employees
- Risk managers and safety officers
- IT system users