Vivaldi QMS

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

 

Document Control

The backbone of your management system: SOP's, instructions, medical device file and documentation. Use version control, electronic signatures, review, distribution, full text search and more.


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Process2Flow

Our workflow module replaces dozens of your Excel files and manual processes: CAPA, incidents, complaints, management of change, audits, calibrations, risk management and more.


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Training Manager

Easy management of training records, skills & competencies. Use training assessment & online exams, full history records, gap analysis, statistics & reporting and more.


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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.

 

GTherapeutics
enterome
Bova
fertipro
RVA
UnionHospital HongKong
XStrahl
Summit
Sphere
Multiplicom
Viroclinics
Rimer
Bioglan
Physiol
Temag
Establishment

Document Control

The 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.


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Incidents & Complaints

Management of incidents with patients, customer complaints, supplier complaints and deviations. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting.


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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.


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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..


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Calibration & Maintenance

Approval, calibration, maintenance and validation of equipment, tools and instruments. Planning, flexible workflow including attachments. Full audit trails. Statistics & reporting.


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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.


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Having Vivaldi QMS for our Quality System has freed us up to concentrate on growing the business.
 

Larry Fishler
Risk & Director of Operations, CryoConcepts

It was a great decision to switch on Vivaldi from Paper based QMS! A lot more efficient to manage the QMS tools and Quality.

Setu Savani
QA Manager, Temag Pharma

Vivaldi Process2Flow has reduced the workload and risks on important regulatory aspects.
 

Jeroen de Jong
Risk & Compliance Manager, Dishman Netherlands

Latest news (blog)

Would you like to have a live presentation of Vivaldi QMS or do you have a question?


Tell us a little about yourself and how we can help you, and we will be in touch right away.


Other ways to contact us:


USA:
+1 781 569 5243
usa@vivaldisoftware.com


UK:
+44 1772 217089
uk@vivaldisoftware.com


Asia:
+65 6221 2905
asia@vivaldisoftware.com


Europe:
+32 56 73 20 20
emea@vivaldisoftware.com

 

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