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Kursusbeskrivelse
Validation of software for QMS process
Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.
Course outcome
Participants at this course will learn:
- The concepts of QMS software validation,
- How to assess risks related to QMS software,
- How to apply IQ, OQ and PQ to QMS software.
Course description
ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process.
Knowing how to combine ISO 13485:2016 QMS software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.
Course outline:
- Introduction
- Validation process
- Inventory
- Selection
- Effort of validation
- Additional criteria for validation
- Design qualification
- IQ, OQ, PQ
- Special cases: Excel, data backup-restore…
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Målgruppe
People working for medical devices or in vitro diagnosis manufacturers:
- Quality Assurance and Regulatory Affairs Managers
- Software Project Managers
- Software Development, Risk Management, and Test Engineers
Pris
Price of this course is 7.830 dkk excl. VAT.
Early bird price: 7.080 dkk excl. VAT.
Om udbyderen
Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse. Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...
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