Vivaldi QMS

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.


Read 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.


Read more


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.


Read 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.

 

analis
cryoconcepts
FlenPharma
DiaSource
RVA
UnionHospital HongKong
Dlm
enterome
CertainTeed
OilDri
Spadel
TCL
DeltaLloyd
Kuwait
Univeg
Infrabel

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.


Read more

 

Complaints

Management of customer complaints, supplier complaints and internal non-conformances. Flexible workflow, including root cause analysis and full audit trails. Statistics & reporting.


Read more

 

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.


Read more

 

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..


Read more

 

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.


Read more

 

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.


Read more

 

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

 

How can we help you?

First Name*

Last Name*

Company*

Country*

E-mail*

Phone*

Your question

Invalid Input