Regulatory Open Forum

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

Brie, Ginger: I believe this discussion may have over complicated the question at hand – what OTS SW options are available for establishing an electronic QMS?  My current employer had evaluated numerous options (TrackWise, Master Control, Minitab 17) before selecting QCBD (Quality Collaboration By Design).  It contains all of the pertinent QMS elements, and leveraged the Vendor’s knowledge and documentation to validate the SW (IQ, OQ, PQ).  What I particularly like about this tool is how we can customize the SW to fit our Quality processes rather than purchasing an OTS package that requires an SOP overhaul to make our processes reflect what the SW offers.  All of this activity is appropriately documented and verified in the test environment before implementing any changes in the production environment.

A few others have mentioned ZenQMS which appears to be similar to QCBD for cost effectiveness, compliance, scalability, etc.  My recommendation is to investigate QCBD and ZenQMS as potential solutions.

Best!

-David

Brie, Ginger: I believe this discussion may have over complicated the question at hand – what OTS SW options are available for establishing an electronic QMS?  My current employer had evaluated numerous options (TrackWise, Master Control, Minitab 17) before selecting QCBD (Quality Collaboration By Design).  It contains all of the pertinent QMS elements, and leveraged the Vendor’s knowledge and documentation to validate the SW (IQ, OQ, PQ).  What I particularly like about this tool is how we can customize the SW to fit our Quality processes rather than purchasing an OTS package that requires an SOP overhaul to make our processes reflect what the SW offers.  All of this activity is appropriately documented and verified in the test environment before implementing any changes in the production environment.

A few others have mentioned ZenQMS which appears to be similar to QCBD for cost effectiveness, compliance, scalability, etc.  My recommendation is to investigate QCBD and ZenQMS as potential solutions.

Best!

-David

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

while I do not endorse any specific software, I would suggest for reduced implementation and cost, that you consider a web based program on a subscription basis.  This approach will greatly reduce the implementation, configuration, and validation costs of a QMS system.  Additionally, these systems are very scalable.  If you wish to send me an email, I can put you in contact with a couple of sources that can provide an in-depth review of their products.

------------------------------
Norman Rabin
Solutions Delivery Leader
Maetrics
Indianapolis IN
United States
nrabin@maetrics.com

while I do not endorse any specific software, I would suggest for reduced implementation and cost, that you consider a web based program on a subscription basis.  This approach will greatly reduce the implementation, configuration, and validation costs of a QMS system.  Additionally, these systems are very scalable.  If you wish to send me an email, I can put you in contact with a couple of sources that can provide an in-depth review of their products.

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

This may not be the answer you want, but I have found from experience in multiple software implementations that the first step is to develop requirements for the software you think you need.  Next, I would follow the GHTF Supplier guidance to select the supplier most likely to meet the requirements that you have established. You might think this is a lengthy process to "just buy software" but buying the wrong product is much more expensive than you might expect.

For instance is the software just going to store documents such as DHF and DMR or will it also provide complaint processing and adverse event reporting features.  These things must be thought out and documented before you look for a supplier that has a record of being able to supply the product that you need, and can support the software.  Don't forget that the software must be validated for its intended use. Will the supplier be able to provide a validation package for you to perform the necessary validation? Each update may require re-validation, that should be part of your determining what package will meet your needs

There is much to think about beyond what package someone else is using.  It is good, however, to get some customer lists of your finalists so you can interview the customers to find our what issues they may have had with a product, and how the supplier responded to these issues.

Hopefully, these thoughts might help you in your process.

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks! 

When it comes to developing user requirements, you might start by determining what functions are offered by the QMS software, then determine whether you need/will need these functions and, if so, how you will need them to work in order to meet your needs.  For example, someone said that they are using their QMS software primarily for design control and risk management.  I would want to know exactly what the software does to support these two functions and how it does it, as well as how much flexibility it offers in terms of how it does it.  The latter seems especially important when considering software for a start-up company.

Personally, I tend to avoid implementing anything electronically until I've worked it out manually first, because for me that seems to be the only way to get a reliable handle on what functions I need and how I will need them to work in order to fit my needs.  If the company doesn't have much of a QMS, then they may not yet be in a position to make these determinations.

I definitely support Julie's comment on getting a system working first before trying to automate it through software.  I have had quite a bit of experience with large software systems that were purchased to take over processes in both cases.  In cases where the system was not worked out first before automating, we found that the software implementation caused more problems than it helped.  It dd not help improve the process, but required us to change our business model to conform to the software in a way that caused more work to be done to complete the business process.

Of course, my original comment on establishing requirements first still applies.  In fact, it is difficult to develop requirements when a "paper system" is not in place and has been exercised to work out its kinks.  Lots of learning takes place in the paper implementation of a process, as most of us have observed in earlier implementation of quality systems. 

I definitely support Julie's comment on getting a system working first before trying to automate it through software.  I have had quite a bit of experience with large software systems that were purchased to take over processes in both cases.  In cases where the system was not worked out first before automating, we found that the software implementation caused more problems than it helped.  It dd not help improve the process, but required us to change our business model to conform to the software in a way that caused more work to be done to complete the business process.

Of course, my original comment on establishing requirements first still applies.  In fact, it is difficult to develop requirements when a "paper system" is not in place and has been exercised to work out its kinks.  Lots of learning takes place in the paper implementation of a process, as most of us have observed in earlier implementation of quality systems. 

I respectfully disagree with the approach: When it comes to developing user requirements, you might start by determining what functions are offered by the QMS software, then determine whether you need/will need these functions and, if so, how you will need them to work in order to meet your needs.

Good practice (see e.g. GAMP) is to define the user requirements and then see which system (paper or electronic or both) provides the best possible match for your needs. You don't buy a 4-seater car and then try and figure out how you can fit 16 people in it. You put down a requirement "car for 16 people needed" and then look which ones will fit your requirements.

Siegfried

I have a client that is interested in purchasing an off-the-shelf QMS software.  They are in an early development phase and don't really have much of a quality system and are looking to just basically adopt something that exists.  They are very budget conscious and looking for something for about 10 users (now) and scalable to about 50 users (3-4 years).

What have you worked with?  What did you like/dislike?

I welcome any recommendations (or condemnations) you may have.

Thanks!