Be sureyour software worksas intended
We help you demonstrate your software is compliant with specifications and regulations.
Validation is a must to assure your software works as expected, compliantly and safely.
Our capabilities
- GAMP 5 approach
- Regulatory Compliance (IEC 62304)
- Software URS
- Software specifications
- Software risk analysis
- Software verification and validation
- FDA Title 21 CFR par t 11 compliance
- GxP approach
- COTS software validation
- Spreadsheet macros validation
- Custom software validation
- Traceability matrix of the requirements
- Safety features testing
- Integration with customer quality management system (QMS)
Experience
- ERP validation (Priority, Mago, Business Central, BPCS...)
- Asset Management Software (Scops.ai, EAM, …)
- Minitab software validation
- Validation of software for manufacturing processes
- Labelling software (NiceLabel)
- Minitab software validation