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Documentation & Control
We offer a comprehensive set of product development documentation
to support our informed design process.
- Plans to guide the development.
- Product definition documents to record product requirements and specifications
- Transfer design files to enable manufacturing to build a product with predictable results (design history file, device master record and device history record)
- Documents are routed and approved over secure network, and encrypted and stored in Citrix Sharefile:
- We meet administrative/procedural requirements of Title 21 CFR Part 11
- Sharefile is identity-access-controlled (username/password/two-step verification required)
- Transfers to Sharefile cloud are over Secure Socket Layer (SSL) / Transport Layer Security (TLS)
- Sharefile storage is in SSAE-16 audited data centers
reliability | realizedLearn more about Informed Design
Acronyms used in the Comprehensive Documentation graphic are defined below:
- PRD – Product Requirements Document
- HA – Hazard Analysis
- SRD – Software Requirements Document
- VVP – Verification & Validation Protocol
- UID – User Interface Requirements
- RA – Risk Analysis plan
- SSR – Sub-System Requirements
- TM – Trace matrix
- SSD – Software Specification Document
- HDD – Hardware Design Document
- ECAD – Electrical CA
- FMEA – Failure Mode Effect Analysis
- FDD – Firmware Design Document
- MCAD – Mechanical CAD
- DHF – Design History File
- DMR – Device Master Record
- DHR – Device History Record
