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URS Builder

Generate customized User Requirement Specifications based on your environment type and regulatory context.

📋 Project Information

🏭 Environment Type

Select the type of environment to customize applicable requirements.

⚖️ Regulatory Context

⚡ Quick Actions

🌡️Measurement Performance
0/3
Temperature measurement accuracy ≤ ±0.5°C
MandatoryWHO TRS 1010, EU GDP
Resolution of 0.1°C or better
MandatoryWHO TRS 1010
Data logging interval configurable (1 min to 60 min)
MandatoryWHO TRS 1010
🔒Data Integrity & Security
0/5
Compliance with 21 CFR Part 11 (electronic records, electronic signatures)
MandatoryFDA 21 CFR Part 11
Complete audit trail with timestamp, user ID, old/new values, reason for change
MandatoryFDA 21 CFR Part 11, EU Annex 11
Role-based access control with unique user credentials
MandatoryFDA 21 CFR Part 11
Data backup with documented recovery procedures
MandatoryEU Annex 11
Data stored for minimum 5 years (or as per retention policy)
MandatoryWHO TRS 1010, EU GDP
🔧Calibration & Traceability
0/4
🗺️Mapping Methodology
0/5
🔔Alarm & Notification
0/5
📊Reporting & Analytics
0/5
🔌Integration & IT
0/5
✅Validation & Compliance
0/5

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0 Mandatory0 Should-Have
# User Requirement Specification

Select requirements from the left panel to generate your URS document.