Is anyone using MasterControl Spark? I have a question

[QAMed26]

Hello everyone

We are a small (less than 15 people) medical device company and we are looking into moving away from a cumbersome paper QMS. MasterControl is quite expensive, however I stumbled upon their Spark Document Management System which says its designed for small companies. Is there anyone out there using them and would you be willing to share approximate cost?

Thanks!

 

[GStough]

Hello everyone

We are a small (less than 15 people) medical device company and we are looking into moving away from a cumbersome paper QMS. MasterControl is quite expensive, however I stumbled upon their Spark Document Management System which says its designed for small companies. Is there anyone out there using them and would you be willing to share approximate cost?

Thanks!

My last company used MasterControl and there were many who disliked it, (including me!) citing it as being not user-friendly. Mind you, it wasn't the Spark Document Management System that you mentioned, but rather the whole program.

If your company is less than 15 people, why wouldn't you consider using SharePoint? I've seen where people here have made the move from paper to SharePoint, and as I recall, they were pleased. I believe it may be free or at the very least, substantially less costly than MasterControl.

I hope this helps.

 

[Miner]

You might also consider using a wiki. Pancho has a thread on a wiki QMS.

Note: you can set up a wiki in SharePoint as well as in other platforms.

 

[QAMed26]

Most likely because we have to be 21 CFR 11 compliant and we don't have the IT resources to accomplish that or to create it for us on Sharepoint.

 

[Miner]

What is your concern relative to 21 CFR 11? Both options have version control. You can also add workflows for approvals and can control the type of access (i.e., read-only).

SharePoint or wikis are not too difficult to learn and create on your own. Its kind of like learning Excel. Most people can do the basics with some study. Yes it does take an expert to do the really advanced stuff, but you probably will not need that.

 

[QAMed26]

My understanding is that version control isn't sufficient.
But regardless, we don't have the resources to do this and are looking at something that is out of the box that we can use.

 

[Pancho]

Mmagargee comment #196 in the wiki thread has links on how he meets CFR 11 requirements with a wiki.

 

[QAMTY]

To implement Share point, not similar to use Excel.
First off.

-You need to have a server (server characteristics or at least a powerful computer)
-To buy Microsoft server license
-To buy Share point software
-To buy licenses for each user
-To have the skills to install and tune Microsoft server software
-To install latest microsoft patches
-To install antivirus
-To configure security
-To configure access to users
-To have the skills to install and configure Sharepoint
-To give training for people
-To customize it use and some configurations

Summarizing, it is not so easy, take care of mentioned issues before deciding
what to do,additionally, you will have to give maintanance to the server OS and to
sharepoint. (security,antivirus, patches,etc.)

Unless you have an IT guy with experience and resources to buy hardware and software, well, Sharepoint could be one option.

Hope this helps

 

[youngm]

I've used the full version of MasterControl for years. The Spark version has basically a lot of the work done for you with regard to vaults, infocard types, numbering etc. I believe you can have it hosted so you don't really need IT to help you. They have technical support that can walk you though anything online through Webex, just call them. You pay maintenance and don't know why more people don't use the support. It is a really good system out-of-the-box, and it is easy to configure how you want it. The audit trail is much better than what you could get out of SharePoint. And who has the time to figure out how to configure SharePoint? Do you want to be beholden to a consultant? You have access to user groups and people you can network with. The software did everything you need it to do. As with any software, you need to train people! And train them again; especially if they don't use the system all the time. Same way with any other program.

 

[ALEONARD]

Hello everyone

We are a small (less than 15 people) medical device company and we are looking into moving away from a cumbersome paper QMS. MasterControl is quite expensive, however I stumbled upon their Spark Document Management System which says its designed for small companies. Is there anyone out there using them and would you be willing to share approximate cost?

Thanks!

I know it's been a few years, but QAMed26 did you end up going with MasterControl Spark and if so, how's it going now? I'm in a similar position and have it narrowed down to a few, including MasterControl Spark