Validation of EffiValidation 3.0
Validation at EffiChem
Since all our products are being developed for use within the regulated laboratory environment, we pay significant attention to the latest regulatory and validation requirements and follow the V-model by ISPE as presented below:
Validation at the End-user place
Because we deliver a true off-the-shelf product with no code development for customization, the design specification or code development and code testing are not necessary. The validation process simplifies to the following four phases:
- Design Qualification (DQ)
- User Requirement Specification
- Vendor qualification
- Installation Qualification (IQ)
- Delivery check against the purchase order
- Installation of software, use of the built-in IQ
- Operational Qualification (OQ)
- Test the key operational functions, use of the built-in OQ
- Test the security functions, more info
- Performance Qualification (PQ)
- Test for specified application (using end-user data), or use Book of Reference examples
- System maintenance
- Ongoing performance testing and monitoring
