They Forced You to Make Documentation. Save Yourself with Automated Compliance
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Vlad Știrbu discusses the importance of automated compliance in software development, emphasizing that traditional documentation processes can hinder productivity. The document highlights various compliance regulations, including ISO standards and the medical device directive, while advocating for modern agile practices tailored to regulated environments. It suggests integrating compliance seamlessly into the development cycle through real-time documentation with every code commit.
They Forced You to Make Documentation. Save Yourself with Automated Compliance
- 1. They forced you to make documentation… save yourself with automated compliance Vlad Știrbu CompliancePal 10.12.2019 @VladStirbu @CompliancePal
- 2. Who am I? Vlad Știrbu ● CompliancePal ● Nokia ● PhD Computer Science
- 3. CompliancePal Software is eating the world Marc Andreessen https://a16z.com/2016/08/20/why-software-is-eating-the-world/ https://earthobservatory.nasa.gov/images/82693/earthrise-revisited
- 4. CompliancePal https://www.dlr.de/dlr/en/Portaldata/1/Resources/bilder/portal/xl_galerie/STS_135_Launch_16_9_xl.jpg Software intensive products 2015 DevOps Today DevOps ++ 1970 Waterfall 2001 Agile
- 5. Modern agile
- 6. “Documentation is not real work.” (not to be named) Lead Front-End Developer CompliancePal@VladStirbu @CompliancePal
- 8. What does the CE mark mean? ● Legislation (EU) ○ Medical Device Directive ○ Medical Device Regulation (from 05/2020) ● ISO technical standards ○ 13485 - quality management ○ 14971 - risk management ○ 62304 - software development life cycle CompliancePal
- 9. ISO 62304: Medical software development life cycle CompliancePal
- 10. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments
- 11. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments developers designers architects management system administrators end-users auditors
- 13. Reality of agile meets regulated environments CompliancePal
- 15. Augmenting GitHub flow for developers CompliancePal
- 16. Augmenting GitHub flow for compliance officers CompliancePal
- 17. Continuous seamless experience Git CompliancePal Developer/ Architect Compliance Officer commit notification status Team chat problems view Backlog compliance issues status CompliancePal
- 18. Start from the beginning Do it during development with each commit Find the real use of the documentation Do it for real, not by obligation