Requirements of Reg (EU) 2021/2226, FDA, ANVISA, TGA, and others
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elFU software validation
User requirements, verification and validation, software risk analysis
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elFU system validation
ISO 13485, Reg (EU) 2017/745, Reg (EU) 2017/746, 21 CFR Part 11. Guidance, document templates for computer system validation and risk analysis, review support)
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Supplier quality management system audits
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Modules
Change control
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Audit log
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Document version management
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Order management
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Product update subscriptions
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EU languages website
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Custom translations
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Paper IFU request handling
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Document lot management
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Geo-defined products
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Documentation
eIFU implementation guide
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eIFU software validation
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eIFU system validation
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eIFU quality assurance templates
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Technical
EU ISO27001 certified data centres
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Availability
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Continuous data backup
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Emergency recovery process
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API integration
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Security
Data encryption at rest
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Data encryption in transit
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DDoS Protection
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Single Sign On (SSO)
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Support
Access to customer support
Standard support
24/7 support
Four-hour first response time
Onboarding training
1 hour
4 hours
8 hours
Onboarding support
4 hours
8 hours
1. All prices are quoted in euros.
2. *Volume related fees apply.
Next steps
Match-making. Organise a non-binding call to review your eIFU needs and to determine if dokspot is a good fit.
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