The title of the lifecycle phase (e.g., Software Development Planning, Software Architecture Design).
An workbook is the most practical tool engineering and QA teams use to track compliance requirements, map software safety classes, and survive rigorous regulatory audits.
For comprehensive, ready-to-use checklists, several vendors offer polished products:
Have software items contributing to hazardous situations been identified? Are risk mitigation measures implemented via software requirements? Have hazardous situations stemming from SOUP been evaluated? 5. Software Configuration Management Process (Clause 8) Iec 62304 Checklist Xls
Three individual columns marking Yes (Y) or No (N) . Class A requires the least documentation, while Class C requires full adherence to all clauses.
Tracking, investigating, and resolving software-related issues. www.qualityfwd.com Safety Classification Impact IEC 62304:2006/AMD1:2015 Checklist .xls file attached
The most effective approach combines a solid checklist foundation with intelligent automation, integrating compliance checks into the tools your development team already uses. Whether you start with a free template from OpenRegulatory or build a custom XLS from scratch, the key is consistency, traceability, and the discipline to verify every item before moving to the next phase. The title of the lifecycle phase (e
The ID of your company’s Standard Operating Procedure that governs this action (e.g., SOP-042: Software Configuration Management ).
This is the core content for the spreadsheet. It outlines the specific activities required by the standard.
Columns are typically assigned to each traceability link: software requirement ID, architectural component, software unit, code reference, and test case. Configuration management ensures your code
Configuration management ensures your code, tools, and documentation are controlled and reproducible.
If the manufacturer does not carry out safety classification, the software and all components fall into the highest safety class C by default.