SBS - The best value in QMS software

QMS and PLM software recommendations

QIE

Registered
#1
We are in the process of evaluating QMS and PLM software packages. Can anyone share experience with Arena, Propel, Master Control or Greenlight Guru? Are there others we should dive into? We're a small company with two manufacturing sites and need to get away from all this paper.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I've used Verse, QT9, and QCBD. I don't believe QT9 will suitably meet requirements for Part 11 but I believe I've seen that the other 2 can. I wasn't involved in setup / tailoring QT9 but the other 2 were sufficiently extensible / tailorable to meet needs.

One thing to be aware of with any such tool: expect to allocate time to setup (and validation since you are in the device forum) and then ongoing care and feeding. After setup, most run mostly unattended but do require some admin support from time to time.
 

yodon

Staff member
Super Moderator
#4
Not in a complete PLM solution, I believe. Strictly document management systems (but they include modules like complaint management, CAPA, etc.)
 

QIE

Registered
#5
Can you elaborate on your experience with Verse and QCBD? Were you generally happy with them and the support/service from the vendor?
 

yodon

Staff member
Super Moderator
#6
I had more interaction with the folks at Verse but both provided good customer service. Both systems were readily configurable for our needs without too much investment in time. Both used workflow diagrams to facilitate the tailoring.
 

lilybef

Involved In Discussions
#7
I have a similar question, but wasn't sure where to put the inquiry. My company is going to transfer the PLM system from Oracle Agile to StiboSystems. Has anyone in the Cove ever worked with that system for medical devices?
 
Thread starter Similar threads Forum Replies Date
M Are We Ready for a QMS? Quality Management System (QMS) Manuals 7
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Remote QMS Coordinator Position Job Openings, Consulting and Employment Opportunities 0
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 7
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
Q New QMS...Old Projects ISO 13485:2016 - Medical Device Quality Management Systems 5
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
S AS9120 Store QMS packages AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Disappointed in leadership buy-in to QMS Quality Manager and Management Related Issues 67
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T How you ensure that QMS is effective and efficient? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
DuncanGibbons Enterprise Architecture for QMS Conceptualization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
I Drupal for QMS Quality Tools, Improvement and Analysis 26
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom