EQMS for small medical device company

Elsmar Forum Sponsor

joemar

Involved In Discussions
#13
All of them are offering live demo. But couldn't find on their web-sites the free trial, except the qmsWrapper.
Do you know if MasterControl and Greenlight Guru offer free trial?
probably too late, but you have to get directed trials with their customer reps. so you go though like 3 stages of them figuring out how serious you are before they let you see the product. and never are able to get your hands on a demo where you can play with things. you just watch them do it.
 

Jeffbbt

Starting to get Involved
#14
Yes and no. I was able to get a trial on one or two, but it wasn’t easy.
I previously mentioned M-Files, as that is what I decided to implement and just validated last week (phew!). I seem to be the only person on this thread who has heard about it, which I am not surprised by as it is natively a Document management system before anything else.
Anyway - I just wanted to provide a caveat to my previous comment - after going through implementation, I want to warn it can get up there in costs if you decide to do any customizations, as we did.
 

James

Involved In Discussions
#15
In my fairly limited experience, I felt that free trials would be pointless, because even with off the shelf systems there will be lots of system configuration to get it to do what you want / how you want. Pick out the key features that are important in an eQMS for you and focus on these in your demo. Price was a big factor for me.

After 4 sales pitches and speaking to existing clients of some of the providers (you must do this - see what existing customers think of features and support), I went for the cheapest. I'm happy with the choice. I'm sure all 4 would have worked fine.

Good luck
 

Jeffbbt

Starting to get Involved
#16
I agree with James, however I did find the trials and demos useful for showing me what I did not want.
Each company has a very different qms, and my reasons for expanding past the cheapest option was because I eventually want to expand the same system into a dms as well as the qms. Also, we deal with a lot of design work rather than individual products (multiple customers, multiple projects) therefore I feel as though our qms needs are different than most.
For me, it was important to avoid the ‘out of the box’ qms templates that check all the boxes but are not actually what you do. I have limited experience as well, but if I could provide any advice it would be to take your time (if you can)!
Good luck.
 

joemar

Involved In Discussions
#18
I agree with James, however I did find the trials and demos useful for showing me what I did not want.
Each company has a very different qms, and my reasons for expanding past the cheapest option was because I eventually want to expand the same system into a dms as well as the qms. Also, we deal with a lot of design work rather than individual products (multiple customers, multiple projects) therefore I feel as though our qms needs are different than most.
For me, it was important to avoid the ‘out of the box’ qms templates that check all the boxes but are not actually what you do. I have limited experience as well, but if I could provide any advice it would be to take your time (if you can)!
Good luck.
Ive been reviewing a bunch of options now and we are mostly looking for something that gives you out of the box usage, but with enough configurability to make it workable. We've reviewed the budget options and the expensive options. the budget ones are just glorified sharepoint folder systems. the expensive ones really integrate processes.

you're right that the price goes nuts though. and im sick of the add on charges for everything.
 

Jeffbbt

Starting to get Involved
#19
Yes - That is a great approach. You can always go expensive later!

I like to envision my approach to quality with a simile: Quality is like good writing. Good writing is very difficult to produce/achieve. It should be concise. Every word needs to be chosen carefully and purposefully, to avoid verboseness.

If you are looking for out of box solutions that are inexpensive, in that case I would recommend the wiki approach that is discussed often. Confluence and Jira are great options, and the plugins you can get are very useful for creating excellent work flows and permission schemes. You can also get some out of box templates to get you moving along faster. One of the plugins I investigated was Comala workflows which I think would be necessary.

I think I already mentioned qmsWrapper as well earlier... there are so many these days its hard to keep track!
 
Thread starter Similar threads Forum Replies Date
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D EQMS - When the internet or system might not be available ISO 13485:2016 - Medical Device Quality Management Systems 7
F Grand Avenue Software, Q-Pulse or Qualio - which for a full eQMS? Medical Information Technology, Medical Software and Health Informatics 1
K EQMS provider's pledge to COVID-19 Misc. Quality Assurance and Business Systems Related Topics 1
S Validation of eQMS - Cloud based out of the box solution Other Medical Device Related Standards 18
S EQMS solution (Greenlight Guru and Q-Pulse currently being explored) Medical Information Technology, Medical Software and Health Informatics 8
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
D eQMS/ERP System Admin Work Instructions - Where do they fit? Misc. Quality Assurance and Business Systems Related Topics 5
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
Proud Liberal Small radius with tight tolerance on a torus General Measurement Device and Calibration Topics 4
shimonv Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19 US Food and Drug Administration (FDA) 17
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J SPC - Stamping parts - Small batch size Statistical Analysis Tools, Techniques and SPC 6
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Gauge Study for Small Lots Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
Nicole Desouza ISO / AS Certification - Small business with less than 100 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
R Inventory management for a small startup device company Other Medical Device Related Standards 1
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
E Question on GD&T added to print - Positional callout for the small holes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
Ed Panek Small Medical Device company - Bring production in-house ISO 13485:2016 - Medical Device Quality Management Systems 1
K Small Sample - Lower Limit Probability Statistical Analysis Tools, Techniques and SPC 0
Z Best Practices - small volume medical device tube cutting (0.020" to 0.080" OD)? Manufacturing and Related Processes 3
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
Tagin Measuring supplier quality with small quantities Statistical Analysis Tools, Techniques and SPC 10
apestate Inexpensive Gage Blocks for small aerospace startup shop General Measurement Device and Calibration Topics 1
I DOE: High variance and small effects in Minitab Using Minitab Software 1
E Small one man shop with QMS (shoptech e2) | AS9100 cert help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 46
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
B ISO 9001:2015 for a Small Machine Shop need Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Le Chiffre Is ISO/IEC 27001 appropriate for most small businesses? IEC 27001 - Information Security Management Systems (ISMS) 2
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
B Medical device manufacturer - Product certification (Small businesses) EU Medical Device Regulations 2
J Requirements for Work Transfer of Small Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P QMS software recommendations for a small ISO 13485 company Quality Manager and Management Related Issues 5
S Need Continuous improvement Suggestions - Small (30 of us) all-CNC machine shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
S Quality Plan at a small Medical Device Company - Is the quality plan a DMR document ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom