Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone. 
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs? 

Thanks in advance.

Original Message:
Sent: 10/20/2022 2:38:00 PM
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone. 
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs? 

Thanks in advance.

Dear Anonymous:

Ease  of use or whatever does not work well with Qualio notwithstanding that you seek answers for-wish to add another food for thought as you evaluate potential eQMS choices.

Medical device manufacturers (or Biologics and Pharma Small molecule drugs) are bound by cGMP which dictates the mandatory need for a quality system and equally important is the quality system trainings mandated by 21 CFR 820 legal statutes through  CDRH.

21 CFR 820.25(a) requires that personnel be given proper background training and  education while

21 CFR 820.25(b) requires that TRAINING be DOCUMENTED.

21 CFR 820.70(d) goes into even more auxiliary training aspects that involve temporary workers in your specific environment and supervised appropriately
"all establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual."

💡 Though admittedly -any eQMS worth considering will include Training documentation and oversight- above suggests a good case for further  due diligence  on how any eQMS integrates with  any chosen LMS (Learning Management System) to support subject matter/ eQMS training that augments your TRAINING DOCUMENTATION per FDA requirement 💡


So:📚  Key take-away  to consider additionally  as you evaluate eQMS is how the vendor platform YOU FINALLY CHOOSE TO ACQUIRE might integrate into whatever training system your company has designated to meet 21 CFR 820 compliance, i.e. get 'two birds in one stone' so to speak. Keyword is 'integration'. My 2-cents worth if I may.

That said - and back to Qualio-pleased to share that Qualio integrated seamlessly -at least it does--with the Canvas LMS we evaluated see video recording shared BELOW to see how we came to that conclusion.  SmartSearch full-text  sample use case  searches are  also included to illustrate  'document' 'control' responsibilities designated into 21 CFR 820 for  the various roles indicated on the LMS assignments.

https://tinyurl.com/4nynhuyp 

Regards,
Ram Balani
CEO eSTARHelper LLC

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
eQMS Integrated into Canvas LMS-with SmartSearch Video
https://tinyurl.com/4nynhuyp 

------------------------------

Original Message:
Sent: 24-Oct-2022 12:46
From: Gail Sauers
Subject: eQMS users: any Qualio users?

I've helped implement Qualio in a medical device organization. It was very easy to do. Qualio provided training and the documents they shared for IQ OQ PQ were great.

We outsourced manufacturing, so I'm not sure how that would affect your implementation, but I was very happy with how easy it was to implement and use.

Best wishes

Original Message:
Sent: 10/20/2022 2:38:00 PM
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

Dear Anon....

Qualio did not make our top 3 because every user has to have a computer login.  With 10-15 employees, that may not be an issue, but we have over 80.  Without a login, their training module is non-functional as you cannot track each person's training to your documention system.  Since training is such a big part of medical device manufacturing, we chose not to use Qualio.

Hope this helps!

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 24-Oct-2022 12:46
From: Gail Sauers
Subject: eQMS users: any Qualio users?

I've helped implement Qualio in a medical device organization. It was very easy to do. Qualio provided training and the documents they shared for IQ OQ PQ were great.

We outsourced manufacturing, so I'm not sure how that would affect your implementation, but I was very happy with how easy it was to implement and use.

Best wishes

Original Message:
Sent: 10/20/2022 2:38:00 PM
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

This message was posted by a user wishing to remain anonymous

This is something we have to consider as well, since we are hovering right around 75 employees and this may make things difficult. Thank you for your feedback!
Original Message:
Sent: 25-Oct-2022 07:41
From: D Michelle Williams
Subject: eQMS users: any Qualio users?

Dear Anon....

Qualio did not make our top 3 because every user has to have a computer login.  With 10-15 employees, that may not be an issue, but we have over 80.  Without a login, their training module is non-functional as you cannot track each person's training to your documention system.  Since training is such a big part of medical device manufacturing, we chose not to use Qualio.

Hope this helps!

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Oct-2022 12:46
From: Gail Sauers
Subject: eQMS users: any Qualio users?

I've helped implement Qualio in a medical device organization. It was very easy to do. Qualio provided training and the documents they shared for IQ OQ PQ were great.

We outsourced manufacturing, so I'm not sure how that would affect your implementation, but I was very happy with how easy it was to implement and use.

Best wishes

Original Message:
Sent: 10/20/2022 2:38:00 PM
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

Dear RAPS Group: (* on eQMS trail*)

So the question that goes begging if there are ANY eQMS vendors out there who offer an eQMS system THAT DOES NOT REQUIRE User-Login/Password, 
       is how do these eQMS vendors fulfill 21 CFR Part 11  classification of  'closed systems' vs 'open systems ?

To be clear - FDA 's 21 CFR Part 11.3(b)  Definitions stipulates:

11.3(b)(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

11.3(b)(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

--------------------------------
Moreover -there's this moniker 'ALCOA' the FDA stipulates-see below.

Do these eQMS vendors FREE of User Log-in/Password entry provide proof of concept that  their systems meet these requirements and ILLUSTRATE HOW THE FDA's ALCOA compliance  ARE achieved ?
Am curious how some of these below are  done without user login/passwords!

• Attributable: You should be able to trace data back to the person or computer system who generated the data.
  
  
• Legible: Data must be clearly readable and permanent.
  
  
• Contemporaneous: Companies should record data at the time the work is done.
  
  
• Original or a true copy: Original data refers to where data is recorded for the first time, whether in an official lab notebook or computer file. True copies are those that have been verified and labeled as such.
  
  
• Accurate: For data to be accurate, it must be complete, consistent, and representative of facts. In addition, corrections must include a record of any changes as well as justification for the change.
• Complete: Complete data includes all the information required to reconstruct events, including documentation of any repeat testing or reanalysis.
  
  
• Consistent: Data should follow a consistent format in terms of how it is recorded and time-stamped.
  
  
• Enduring: Manufacturers must maintain data so that it's intact for the required retention period.
  
  
• Available: Data must be accessible throughout the data retention period.

Seriously - in today's time of rampant cyber hacks and cyber security exposures and failures -- is the trade-off of easy user access worth the risk of a not-so-tightly controlled eQMS system which requires User Log-in/Password and in some cases even a verification-code authentication also provided?

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 25-Oct-2022 13:44
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

This is something we have to consider as well, since we are hovering right around 75 employees and this may make things difficult. Thank you for your feedback!
Original Message:
Sent: 25-Oct-2022 07:41
From: D Michelle Williams
Subject: eQMS users: any Qualio users?

Dear Anon....

Qualio did not make our top 3 because every user has to have a computer login.  With 10-15 employees, that may not be an issue, but we have over 80.  Without a login, their training module is non-functional as you cannot track each person's training to your documention system.  Since training is such a big part of medical device manufacturing, we chose not to use Qualio.

Hope this helps!

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 24-Oct-2022 12:46
From: Gail Sauers
Subject: eQMS users: any Qualio users?

I've helped implement Qualio in a medical device organization. It was very easy to do. Qualio provided training and the documents they shared for IQ OQ PQ were great.

We outsourced manufacturing, so I'm not sure how that would affect your implementation, but I was very happy with how easy it was to implement and use.

Best wishes

Original Message:
Sent: 10/20/2022 2:38:00 PM
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

Hey, 
I have been through multiple eQMS changes, and now I do work for Sparta Systems, Honeywell.  
My advice, is have a meeting and ensure that there is a clear picture of where the company wants to be in 3-5 years.
If the organisation wants to move with the trends of digital transformation then without a doubt you need to choose a system that can use connectors to pull data from other systems (training, operations, PM, ERP, etc.).  
If the organisation is not planning on approaching the digital era then the connectivity will not matter. 

You don't want to move to a system which will be siloed in a year.

------------------------------
Zillery Fortner
Product Advisor QA/RA Life Science
Hamilton NJ
United States
------------------------------

Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

My recommendation from many cases of choosing and implementing software systems in a medical device company, is to start with writing a requirements document, including things like Zillary mentioned. 

it is not a good idea to just ask what others are using, because they might not have the same needs as you. When you have requirements identified, in writing, then you can search for possible suppliers (and remember the purchasing requirements of the regulations here).  And don't forget product support after the sale and update processes  

Next, you can select potential suppliers and get access to their products to test against your requirements. Finally, you can select the right product for your company.  The process will be lengthy as after you install it and configure it to your company, then finally validating the software as required for all software impacting the quality system. And any time the software is updated or changed, you must look at the validation requirements, before you implement the change. 

I have been through both successful and failed software implementations and strongly suggest you start with your requirements and not be distracted by the flashy advertising thing the salesman shows you, with nothing behind it. 

------------------------------
Edwin Bills MEd, BSc, RAC, CQE, CQA, CMQ/OE, ASQ Fellow
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 25-Oct-2022 10:31
From: Zillery Fortner
Subject: eQMS users: any Qualio users?

Hey,
I have been through multiple eQMS changes, and now I do work for Sparta Systems, Honeywell.
My advice, is have a meeting and ensure that there is a clear picture of where the company wants to be in 3-5 years.
If the organisation wants to move with the trends of digital transformation then without a doubt you need to choose a system that can use connectors to pull data from other systems (training, operations, PM, ERP, etc.).
If the organisation is not planning on approaching the digital era then the connectivity will not matter.

You don't want to move to a system which will be siloed in a year.

------------------------------
Zillery Fortner
Product Advisor QA/RA Life Science
Hamilton NJ
United States

Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

This message was posted by a user wishing to remain anonymous

Hi there..... I am currently implementing Qualio. In fact, this week I am working on getting my staff all trained. We are a very small medical device company.  It is "OK".....has its pros and cons (as does everything). For the last 15 years I had a manual QMS that was never an issue for any FDA inspection or ISO audit....so this is a HUGE change for me to get used to. I do like many of the features that will definitely make my life easier. The more I work with the system the more I understand how to use it effectively. Qualio is constantly updating the software as they find bugs. They are very responsive to their users feedback. Therefore as things arise, they are quick to implement a fix to satisfy their users requirements.
Right now my only negative is the editing tool.  They intend to release that software upgrade by 4Q, however, new users automatically get the new editing tool.
Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

I agree with your feedback. The new editor will be released very soon.

------------------------------
Abhilash Ghanwat
QA-RA Specialist
------------------------------

Original Message:
Sent: 24-Oct-2022 09:35
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi there..... I am currently implementing Qualio. In fact, this week I am working on getting my staff all trained. We are a very small medical device company.  It is "OK".....has its pros and cons (as does everything). For the last 15 years I had a manual QMS that was never an issue for any FDA inspection or ISO audit....so this is a HUGE change for me to get used to. I do like many of the features that will definitely make my life easier. The more I work with the system the more I understand how to use it effectively. Qualio is constantly updating the software as they find bugs. They are very responsive to their users feedback. Therefore as things arise, they are quick to implement a fix to satisfy their users requirements.
Right now my only negative is the editing tool.  They intend to release that software upgrade by 4Q, however, new users automatically get the new editing tool.
Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

Hello ,
I am implementing Qualio in our medical device organization. In my experience, overall the Qualio Plus feature is good because they provide onboarding and integration help. We are a small start-up so we had to start from scratch.
The unique part is that documents are drafted and edited in the QMS system. So, if you are used to MS Word/Google docs for editing, it is a small learning curve. However, they are very quick with providing customer support and adding new features to the QMS software. I am happy to offer more in-depth feedback if necessary. 

Thanks.

------------------------------
Abhilash Ghanwat 
QA-RA Specialist
------------------------------

Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.

This message was posted by a user wishing to remain anonymous

My company has been using Qualio for about 3 yrs, initially as a small start-up, and now somewhere around 100 employees. The best features in Qualio are that it is flexible (easily customized) in format, provides a unique module for activities performed in progression (CAPA, complaints, etc), and is capable of interfacing with common business programs. It is true that the training program requires employee access, but it is logical to have that arrangement in an all-digital environment, i.e., no hard copy work instructions to go out of date, get damaged or lost. Plus the audit advantages of having everything at your fingertips. True the document edit and review currently leaves something to be desired, soon to improve. That's my 2 cents.
Original Message:
Sent: 20-Oct-2022 14:37
From: Anonymous Member
Subject: eQMS users: any Qualio users?

This message was posted by a user wishing to remain anonymous

Hi everyone.
I work for a small, but growing startup company and we are in the middle of evaluating two eQMS systems. While we have a good amount of feedback from others in industry that have utilized the first option, we are still trying to evaluate the 2nd one, Qualio, and have not run into any connections in the med. device industry that are utilizing this platform.

Can anyone give feedback? We've seen the demos and sandbox of what can be achieved (which is good), but we don't hear the negative sides obviously from those giving the demonstrations. Anyone out there using or used this software in the past for their eQMS needs?

Thanks in advance.