Your medical devices business deserves better than a "manual" Quality management system!
Vivaldi QMS is software for the management of documents & documentation, complaints, CAPA & corrective actions, audits, training records, incidents & accidents and more.
ISO 13485 - GxP - FDA - ISO 9001 - ISO 14001 - OHSAS 18000
Document Control
The core and backbone of your quality management system: procedures, manuals, instructions, instructional text and documentation. Use version control, assessments, distribution, PDF conversion, full text search and more.
Process2Flow
Our workflow module can replace dozens of applications, Excel files and Access files: complaints, CAPA, audits and more. Let your imagination run wild and use Process2Flow to handle more of your company processes every day.
Training Manager
Easy management of training records and skills & competencies. Training Manager is compliant with ISO 13485, FDA (21 CFR Part 11), GxP and other standards. Use assessment & exams, full history records, gap analysis, statistics & reporting and more.Medical devices companies love Vivaldi QMS.
Vivaldi Software has been developing Quality Management software and software for Regulatory compliance since 1995.
More than 75,000 users in the medical devices industry or other industries spread across more than 20 countries use our Quality Management Software on a daily basis.
Document Control
The core and backbone of your ISO 13485, FDA (21 CFR Part 11) and GxP compliant quality management system: procedures, manuals, instructions, instructional text and documentation.
Complaints
Management of customer complaints, supplier complaints and internal non-conformances. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting.
CAPA
Management of corrective & preventive actions (CAPA) and general tasks. ISO 13485, FDA (21 CFR Part 11) and GxP compliant. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting.
Audits
Management of internal and external audits, follow-up actions and related non-conformances. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting..
Incidents & accidents
Management of incidents, accidents and safety related non-conformances. Follow-up actions. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting. Training Management
Management of training records and skills & competences matrix. Optional assessments or exams after a training session. Full history and audit trails. Statistics & reporting.
