SBS - The best value in QMS software

Sharepoint for ISO 13485 QMS for small IVD company

#1
Hi,

Does any of you have experience with using Sharepoint for a 13485 compliant QMS for a small IVD company?

We are looking into whether it would be possible to find a consultant who could be responsible for creating the overall structure of the QMS, rather than having one of our own employees to do it since it will take time in training.

If you know the right person or alternative solution please feel free to suggest.

Regards
Emil
 
Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
There is a great deal of content on the Cove related to off the shelf eQMS solutions that may already have some level of validation by the provider. Typically, the customer only needs to do an IQ and then have a process for managing updates (validating changes). I would not advise using SharePoint as a solution. I am not aware of anyone with a validated 21 CFR 11 compliant QMS that relies on that MS platform. Here's a WL cite (a bit dated) for an org that did not validate it adequately.

http://www.ofnisystems.com/media/ucm173977.pdf
 
Last edited:

yodon

Staff member
Super Moderator
#3
Regarding your consultant question, there's a forum for that. :)

SharePoint has some interesting features but there's nothing built in that would enable a 'turnkey' QMS support system. As @William55401 points out, there are a number of eQMS solutions, some very expensive, some not so bad. Realize that if you go with a solution like SharePoint, you'll be investing a lot of time building up the infrastructure. I think the tools are probably in place to build it up and make the system compliant (no e-signature capability, though). And also realize that with an eQMS system, you'll still likely need to invest some time in setting up workflows aligned with your company's operations.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
When I worked at the VA they partnered with a local university. They had asked me to develop a QMS based on 13485 using SharePoint. I was able to create a workflow for documents and set up permissions and revisions. We were also able to set up a trace matrix for DI to V&V reports. Beyond that, though it was a challenge.
 

gard2372

Quite Involved in Discussions
#6
Emil,

We are in the process of rolling out our Enterprise wide SharePoint on our Microsoft 365 platform. I did compare many EQMS platforms (ETQ, HQMS etc...) from cost, QMS functions, scaleability, IT integration ease, ease of use and one that was made for quality people not just a bolt on module in an existing ERP platform that is not designed for quality people.

Being a small company, I recognize cost is a factor which is also why we chose BPA as the cost per user is relatively lower than my experience with larger platforms.

We've decided on implementing the BPA Solutions QMS app that rides on top of the SharePoint Platform. With our Microsoft 365 platform, we can easily manage workflows, responses etc... more easily as our entire communications platforms are Microsoft.

Software Validation with BPA Quality & Risk Management


(Not a paid consultant nor being compensated by BPA Solutions)
 

yodon

Staff member
Super Moderator
#7
Ooh, thanks for that tip. I'll look into BPA solutions. I work with a lot of customers in the small / startup / no funds category.
 
#8
Thanks everyone for the input!

Emil,

We are in the process of rolling out our Enterprise wide SharePoint on our Microsoft 365 platform. I did compare many EQMS platforms (ETQ, HQMS etc...) from cost, QMS functions, scaleability, IT integration ease, ease of use and one that was made for quality people not just a bolt on module in an existing ERP platform that is not designed for quality people.

Being a small company, I recognize cost is a factor which is also why we chose BPA as the cost per user is relatively lower than my experience with larger platforms.

We've decided on implementing the BPA Solutions QMS app that rides on top of the SharePoint Platform. With our Microsoft 365 platform, we can easily manage workflows, responses etc... more easily as our entire communications platforms are Microsoft.

(Not a paid consultant nor being compensated by BPA Solutions)
Thank you very much for the suggestion gard2372.

I have now been looking into the BPA solution and it does indeed seem quite flexible. Have you started your work on the platform yet? If so how do you find it performing?

And how long did it take to set up?

Kind regards
Emil
 
#9
Hi,
Thanks for the discussion on this topic.
I am also looking for a eQMS Solution/ Application and being a Start-up we're not looking for something fancy or expensive.
@grad2372 and @EMIL can you share your experiences with this BPA Solutions, if you eventually went ahead with them.

Our company need to be compliant to ISO 13485, ISO 14971 as well as FDA and Health Canada Regulations. Do you think BPA would work with them?
And my understanding is that BPA is kind of an AddOn working with SharePoint. Would also confirm how does that work?
 

mmasiddiqui

Involved In Discussions
#10
Hi,

Does any of you have experience with using Sharepoint for a 13485 compliant QMS for a small IVD company?

We are looking into whether it would be possible to find a consultant who could be responsible for creating the overall structure of the QMS, rather than having one of our own employees to do it since it will take time in training.

If you know the right person or alternative solution please feel free to suggest.

Regards
Emil
I have experience transitioning and establishing ISO 9001:2015 using SharePoint site. It is a bad idea having external consultant do this job for your company. After the consultant is done, there will be very little ownership from your stakeholders internally.
It is not that difficult to work internally.
 
Thread starter Similar threads Forum Replies Date
C SharePoint Contract Management Software General Information Resources 0
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
T Sharing SharePoint Documents Document Control Systems, Procedures, Forms and Templates 4
M MS Power Automate/Sharepoint Files Document Control Systems, Procedures, Forms and Templates 1
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
GreatNate QMS in SharePoint - Is anyone doing this? Manufacturing and Related Processes 10
QIE Anyone have experience with BPA Quality (QMS system based on Office365/Sharepoint) Quality Assurance and Compliance Software Tools and Solutions 1
M Change Orders in SharePoint Document Control Systems, Procedures, Forms and Templates 3
Marc ASQ Linkedin Group - Microsoft Sharepoint discussion - June 2017 Quality Assurance and Compliance Software Tools and Solutions 0
xfngrs Automotive Industry Nonconformance Database wanted - Preferably SharePoint based Quality Assurance and Compliance Software Tools and Solutions 5
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
E Recommendations for Quality Management Solution in SharePoint Quality Assurance and Compliance Software Tools and Solutions 5
K Revision Status Identified only in Sharepoint Document Control Systems, Procedures, Forms and Templates 2
P SharePoint in a Manufacturing Environment Quality Assurance and Compliance Software Tools and Solutions 6
M How to analyse document usage for Sharepoint? Document Control Systems, Procedures, Forms and Templates 4
J Change in our SharePoint Document Control Process - Is this ok? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J File Name Revisions in SharePoint Document Control Systems, Procedures, Forms and Templates 5
M Part 11 Compliant Digital Signature Requirements - Sharepoint Qualification and Validation (including 21 CFR Part 11) 1
P SharePoint for Document Control - 'Workflows' using SharePoint 2010 Enterprise Document Control Systems, Procedures, Forms and Templates 3
C Control of Documents - Converted online in SharePoint Document Control Systems, Procedures, Forms and Templates 9
H 4.2.3 Document Control using Microsoft Sharepoint - Visibility of Draft Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C World Population Clock as Web Part in SharePoint Document Control Systems, Procedures, Forms and Templates 1
V Suggestions on Organizing Documents using SharePoint 2010 Document Control Systems, Procedures, Forms and Templates 13
V Electronic Document Control Sharepoint Questions Document Control Systems, Procedures, Forms and Templates 2
M Microsoft Sharepoint as Document Control Software - FDA Validation Requirements Document Control Systems, Procedures, Forms and Templates 15
J Document Control Software - Sharepoint Document Control Systems, Procedures, Forms and Templates 14
SteelMaiden SharePoint 2007 - tips, tricks or tools? After Work and Weekend Discussion Topics 5
N Anybody with experience with Sharepoint portal for electronic document control? Document Control Systems, Procedures, Forms and Templates 53
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 8
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1

Similar threads

Top Bottom