Implementing an ISO 13485 QMS Software

[JCarlos]

Hi everyone,

While implementing the QMS, it was brought up to the table the feasibility of pursuing a QMS software. At least from the get-go, to control the following elements:

- Document Control (obsolete docs, history of revisions, release of effective docs, e-signatures)
- Training (training logs of all employees, link up doc control)

Management thinks those two elements are working fine through a paper-based/shared drive-managed system, but would rather "facilitate it" with a QMS software.

In your experience:
1. For those two elements, is the expense and validation process of a QMS software worth for those two elements?
2. If so, which softwares do you recommend?

Thank you!

 

[subbash]

Hi everyone,

While implementing the QMS, it was brought up to the table the feasibility of pursuing a QMS software. At least from the get-go, to control the following elements:

- Document Control (obsolete docs, history of revisions, release of effective docs, e-signatures)
- Training (training logs of all employees, link up doc control)

Management thinks those two elements are working fine through a paper-based/shared drive-managed system, but would rather "facilitate it" with a QMS software.

In your experience:
1. For those two elements, is the expense and validation process of a QMS software worth for those two elements?
2. If so, which softwares do you recommend?

Thank you!

Hi @JCarlos ,

We have been using GreenlightGuru QMS software and are satisfied. It simplifies a lot of tasks including Document Control, Training etc. You may review the tool.

 

[William55401]

Google is your friend including old threads on the Cove. Do your own due diligence about what makes sense for your org. Given the size of your org, QMS software validation may be a distraction. As part of your screening criteria, I would include provider shared validation tools / assistance as a selection criteria. For example, do they share templates for you to use to confirm it is installed correctly and functioning?
One more to think about. I was in a similar place as you supporting a small device client. As I got into screening, not all packages had integrated training routes as part of document updates. For the org I was supporting, that was important and caused at least one (my memory fails me) to fall out of the process.

 

[JCarlos]

Hi @subbash,

I've been hearing good comments about Greenlight Guru so far. If you don't mind me asking:

1. Have you found any small deficiencies for this software option?
2. How was your validation process?

 

[JCarlos]

Hi @William55401,

I agree, a research on the Cove and Google has showed me different opinions... some following the QMS software route, while others recommend sticking to the shared-drive system. You got a fair point, I just don't want to waste too much time on validating a system (if it's not crucially needed). I'm sure asking beforehand about the validation tools/assistance that these softwares provide would be a great way to establish who may convenient (if any).

And thanks for the heads up. I know they tend to separate their options per modules, but I'll be making sure to confirm any document control updates are linked to employee's training as well (since those are the two points we would like to cover up with the QMS software, from the get-go).

 

[Katana_Clarity]

I was at the in the same predicament last year. Finally, after looking through several vendors that would suit a small startup get eQMS, we finally choose ZenQMS.

 

[joemar]

I was at the in the same predicament last year. Finally, after looking through several vendors that would suit a small startup get eQMS, we finally choose ZenQMS.

how's it going?

 

[med_cert]

Does anyone have any experience with following quality management solutions (also document management): MasterControl, TrackWise, SAP...?

If you have any experience, please let me know your feedback.

 

[Tidge]

This is just my experience: Folks aren't usually clear what they want a QMS system to actually do, and if the OTS solution is actually designed to do those things. Many OTS solutions can be made to do other things, but this is where it gets hairy.

Here are some things things that a quality system is concerned about, but not all systems do all these things well. Some don't do any of these things well.

• Life-cycle control of procedures (including review & approval)
• Life-cycle of part objects (e.g. DMR)
• Traceability of part objects with inventories (or other cost centers)
• Training / Human resources
• Archival/Access/Approval of records
• Process flow for QMS processes (e.g. CA/PA)
• Traceability among discrete pieces of information from records (e.g. Risk Files, DHF)

The best sales people and customers (of QMS software systems) will know precisely what sort of tasks they want the system to do, too many focus on solving some specific problem. For example: don't just start dropping records in a document life-cycle management system just because it has a "search function".

 

[Billy Milly]

I had a look at Grenlight guru a few years back. I got a good impression on the demo and all "specific" aspects (e.g validation, audit support...) were described as well established. In the ed, price was not suitable for our organisation.
We ended up purchasing a software allowing process modelling (determine action, determine recipients, follow closure, provide alerts...). It works very well for us (for example, we intend to expand our doc management process to include training on changes in procedures, training of new employees, add links to other processes - for example, our design drawings are an input for establishing process insspection, etc).
It is very nice to have "free hands", however we have to justify our decisions ourselves with no or little support. And one more aspect that can be off-putting: Software validation. We develop the software, test, prepare protocols, train and perform validations internally. Much more flexibility, but also much more (short or mid-term) work than a "decent" (compliant) off-the-shelf.