User Requirement Specification EffiValidation 3.0
The User Requirement Specification (URS) EffiValidation 3.0 has been
developed by EffiChem to help customers to specify their requirements related to
the system architecture, functionality, security and compliance with the ISO
17025 and GMP regulations.
This document covers the following areas:
- IT system requirements
- Archival, backup and recovery
- Access control and account privileges
- Audit trail
- System configuration
- Method validation
- Uncertainties estimation
- Control charts
- Calibration
- Inter-laboratory comparison
- Electronic laboratory logbooks
- Software validation
- 21 CFR Part 11: Electronic records and signatures
The standard URS can be customized on request to better cover the specific user requirements and expectations of the customer. Request example URS using the form below:
