To build an efficient tracking sheet, set up your Excel workbook with the following column headers:
Are software creation procedures (build scripts, environment parameters) archived? Applicability: Classes A, B, C. 2. Software Risk Management Process (Clause 6)
Dropdown menu containing Compliant , In Progress , Not Started , or Not Applicable .
1. General Requirements & Software Safety Classification (Clause 4) Iec 62304 Checklist Xls
Check how this aligns with quality systems on I3CGlobal .
Verify the complete, integrated software against overall system requirements.
Maintaining a history of changes to understand what went into a specific release version at any point in time. 5. Clause 9: Software Problem Resolution Process To build an efficient tracking sheet, set up
Your spreadsheet tabs should be divided into the five main lifecycle processes outlined in the standard. 1. Software Development Process (Clause 5)
The standard relies heavily on a risk-based approach, assigning software to one of three safety classes based on the potential severity of harm to patients or users: No injury or damage to health is possible. Class B: Non-serious injury is possible. Class C: Death or serious injury is possible.
Defines how changes and bugs are managed post-release, tied closely to ISO 14971 risk management. Software Risk Management Process (Clause 6) Dropdown menu
Ensuring coding standards were followed and unit testing was completed.
Analyzing root causes and looking for trends across bug logs.