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Comparing Quality System Software Features

S

stephenliu

#1
I'm doing research on Quality Assurance and Quality Control software for my company. I got four software companies from market as options: Master Control, Intelex, CEBOS and ETQ. I have no experience on any of them. Anybody can give me some hints or idea about these software? I really appreciate...

Our company is an electronic/IT hardware manufacturer. It has around 200 employees. We are setting up Agile for product life cycle control. I want to use another software for common quality assurance and quality control such as company-wide document control, quality records, SPC, CAPA, etc..
 
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Jen Kirley

Quality and Auditing Expert
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#3
Welcome to the Cove stephenliu!

I don't have any experience with any of those brands, but I wondered if they can give you any materials, or even a trial version, that can show you the features. I would be particularly interested in

1) The function and simplicity of handling engineering changes to controlled documents

2) Whether/how they handle and present data. What are their audit metrics? I would look for more imagination than "Number of audits, number of CARS issued" which are subjective measures

3) Does the software allow shared responsibilities/ interaction between groups that share responsibility in a process? I am thinking of an Approved Vendor List, in which Purchasing, Engineering and Supply Quality Engineers could all have input for

These are issues that I do have a great deal of experience with, in which the enterprise software's shortcomings did constrain the QMS good performance.

I hope this helps!
 
S

stephenliu

#4
You inspired me... Jennifer, Thanks! Cross functional interaction is really important consideration. I haven't got chance to see demos. I will check it when I try them. Thanks!
 
L

LNeJame

#5
Hi stephenliu,

I used to work for a quality management software provider, I do not anymore and it wasn't any of the companies youve listed.

In my opinion the best place to start is by developing a requirements document internally that outlines as specifically as possible what your needs are, the essentials for what the software needs to do.

I think there are two ways to approach looking at a software solution for QMS. Either you conform your processes to the way the software you choose works or you conform the software to work for your processes.

I think its better to have the software conform to your already structured processes. This can be done either through configuration or customization. The differences between the two configuration is typically a change you can make to the software yourself, customization is a change that you need to go back to the vendor to do. A word of warning if you need customization find out how much it will cost. I've seen projects double or more in cost because they needed a lot of unexpected customization.
 
S

stephenliu

#6
Hi stephenliu,

I used to work for a quality management software provider, I do not anymore and it wasn't any of the companies youve listed.

In my opinion the best place to start is by developing a requirements document internally that outlines as specifically as possible what your needs are, the essentials for what the software needs to do.

I think there are two ways to approach looking at a software solution for QMS. Either you conform your processes to the way the software you choose works or you conform the software to work for your processes.

I think its better to have the software conform to your already structured processes. This can be done either through configuration or customization. The differences between the two configuration is typically a change you can make to the software yourself, customization is a change that you need to go back to the vendor to do. A word of warning if you need customization find out how much it will cost. I've seen projects double or more in cost because they needed a lot of unexpected customization.
Yeah.. there is no software exactly match with an existing QMS system, even I can modify my system but there's bottom line. A software with flexible and wide configuration options should be very important... Thanks for the help!
 
I

Ikrion

#7
We are currently in the final stages of selecting a QMS. We evaluated the following:

Master Control
QUMAS
EtQ
Pilgrim
Oracle Agile (as part of PLM)
TrackWise
Intellex

We started by setting up a User Requirements Document (URD) to describe exactly what we needed, before we started looking. After that, asked for references, searched the web, etc. From our URD we then set up a scoring matrix for each essential attribute, as well as a few others we felt would be important such as stability of the partner company, etc.

We began by reading available white sheets on each vendor's website, then watching recorded webinars, then requesting product demos, etc. All the while in the process, we continued to review the available webinars and white papers routinely to ensure our learning of the product was complete.

Ultimately, we narrow the field down to two: Pilgrim and EtQ. We are doing a Proof of Concept (POC) with each to have our users work with the software and provide us feedback. From the results of the POCs (and reference calls over the next two weeks), which are back-to-back, we will be making our selection.

Something important is that all key stakeholders are involved in the development of the URD. IT and Business Integration, for example, have been key in determining which solution would be best. You also have to make sure you're not stomping on the playground of another department.

For basic impressions so far:

Master Control - Cost effective, used by FDA's ORA, but definitely the cheaper solution
QUMAS - Not enough modules, but slick. We like the SharePoint integration
EtQ - A good contender. A lot of modules out of the box. User interface could be better. It's cost effective and has good theory
Pilgrim - Slick interface, specialized for Life Sciences. Could use more out of the box solutions
Oracle Agile - We only looked at the Quality part of it, and it appears to be an add on. If the company goes with a PLM, the QMS will talk to it, but not be part of it
TrackWise - The platform isn't really an Off-The-Shelf (OTS) solution. It is so highly customizable that it can seem overwhelming. However, if you are just looking for a single module, or are going to start slow, the interface is amazing . It is also the most expensive.
Intellex - The interface was wonderful, however, we had serious concerns about the modifications needed to make it Part 11 compliant
 
R

RMain

#8
Hi
Don't have any experience in any you’ve noted but have reviewed / selected QMS SW, I was concerned with:
1. Can the program pull existing data into buckets of information?
2. Can individuals sign agreement with a PIN style number for imprinting approvals?
3. Can the program facilitate auto routing for approvals/
4. Can the program facilitate importing objective evidence documents as attachments?
5. Can the program interface with existing programs to reduce typing in data info such as part number descriptions, supplier names etc…
6. Can the program minimize free script like typing in several styles of names or abbreviations/slang descriptions, which would contaminate capturing data harvesting.
7. Plan out all your data points you want to harvest ensuring there is a selection box or pull down selection for each selection.
8. Ensure the program has the ability to create reports and dump into a excel spreadsheet so you are not limited to only the reports supplied by the governing software.
9. Ensure that the program allows you to create a depository (a sandbox of data to play with, which will not interfere with live data, facilitating the ability to explore/learn options with familiar data, moving forward and expanding the current views or capabilities.
10. Don’t get caught with S/W which is only suited for the bean counter’s in your company which has a thin veil of limited Quality attributes with no substance.

My two cents
 
I

Ikrion

#9
10. Don?t get caught with S/W which is only suited for the bean counter?s in your company which has a thin veil of limited Quality attributes with no substance.

My two cents
Definitely important. I've worked with systems like that before and they just simply don't function (fail validation, lose data, extremely limited features). A better job can be done with an Access database.
 
S

stephenliu

#10
We are currently in the final stages of selecting a QMS. We evaluated the following:

Master Control
QUMAS
EtQ
Pilgrim
Oracle Agile (as part of PLM)
TrackWise
Intellex

We started by setting up a User Requirements Document (URD) to describe exactly what we needed, before we started looking. After that, asked for references, searched the web, etc. From our URD we then set up a scoring matrix for each essential attribute, as well as a few others we felt would be important such as stability of the partner company, etc.

We began by reading available white sheets on each vendor's website, then watching recorded webinars, then requesting product demos, etc. All the while in the process, we continued to review the available webinars and white papers routinely to ensure our learning of the product was complete.

Ultimately, we narrow the field down to two: Pilgrim and EtQ. We are doing a Proof of Concept (POC) with each to have our users work with the software and provide us feedback. From the results of the POCs (and reference calls over the next two weeks), which are back-to-back, we will be making our selection.

Something important is that all key stakeholders are involved in the development of the URD. IT and Business Integration, for example, have been key in determining which solution would be best. You also have to make sure you're not stomping on the playground of another department.

For basic impressions so far:

Master Control - Cost effective, used by FDA's ORA, but definitely the cheaper solution
QUMAS - Not enough modules, but slick. We like the SharePoint integration
EtQ - A good contender. A lot of modules out of the box. User interface could be better. It's cost effective and has good theory
Pilgrim - Slick interface, specialized for Life Sciences. Could use more out of the box solutions
Oracle Agile - We only looked at the Quality part of it, and it appears to be an add on. If the company goes with a PLM, the QMS will talk to it, but not be part of it
TrackWise - The platform isn't really an Off-The-Shelf (OTS) solution. It is so highly customizable that it can seem overwhelming. However, if you are just looking for a single module, or are going to start slow, the interface is amazing . It is also the most expensive.
Intellex - The interface was wonderful, however, we had serious concerns about the modifications needed to make it Part 11 compliant
Hi Ikrion,

Thank you so much for the information! We are a manufacturer in computer hardware industry. Looks ETQ and Intellex could be good options.

Stephen
 
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