Medical Device businesses deserve better than a "manual" Quality management system!
Vivaldi QMS is software for the management of CAPA, incidents, complaints, SOP's, documentation, audits, management of change, training records and more.
ISO 13485 - GxP - FDA (21 CFR Part 11) - GAMP5 - CE
Medical Device companies love Vivaldi QMS.
Vivaldi Software has been developing software for Regulatory Compliance & Quality since 1995.
More than 75,000 users in highly regulated industries like the medical device industry or pharmaceutical industry use our software solution on a daily basis.
We have successfully implemented Vivaldi QMS in more than 20 different countries.
We offer an extremely flexible out-of-the-box solution including full service: installation, implementation, training and if required assistance with the software validation.
Vivaldi QMS can be deployed On-Premise or in the Cloud.
Document ControlThe core and backbone of your ISO 13485, FDA (21 CFR Part 11) and GxP compliant quality management system: SOP's, procedures, manuals, instructions, medical device file and documentation.
Incidents & ComplaintsManagement of incidents with patients, customer complaints, supplier complaints and deviations. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting.
CAPAManagement 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.
AuditsManagement of internal and external audits, follow-up actions and related non-conformances. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting..
Calibration & MaintenanceApproval, calibration, maintenance and validation of equipment, tools and instruments. Planning, flexible workflow including attachments. Full audit trails. Statistics & reporting.
Training ManagementManagement of training records and skills & competences matrix. Optional assessments or exams after a training session. Full history and audit trails. Statistics & reporting.