Paperless Compliance - Planning to set up an ISO 13485 compliant QMS

Hi, all. I am a long-time lurker here at the Cove, but first time poster.

I am planning to set up an ISO 13485 compliant QMS for my company in the near future, and I'd like to avoid having stacks and stacks of binders and paperwork. Accordingly, I'm trying to find compliance software that makes sense for our system. We're doing small manufacturing of a Class I device, so I don't need anything complicated, but it seems that there are thousands of options out there.

Does anyone have any experience with particular paperless compliance software? I'd love to keep the whole thing completely paperless, which means I'd only be interested in something with 21 CFR 11-compliant electronic signature and document control capabilities.

I'm reluctant to buy before trying, but I also don't want to spend months going through free trial after free trial. Any information you could provide from your own experience or recommendations of reviewers would be great.

By the way, we may be moving in a CE-marked product in the future, so something that works with MDD stuff would be great. If you can point me to something that's also suitable to JPAL compliance, I'd love it. I suppose all of that could be addressed by a company that's good with customizing their default software based on customer requirements.

Thanks in advance!

For some applications I used to use Trackwise. I think it was user friendly and it was adapted to our needs

asfharrison said:

Hi, all. I am a long-time lurker here at the Cove, but first time poster.

I am planning to set up an ISO 13485 compliant QMS for my company in the near future, and I'd like to avoid having stacks and stacks of binders and paperwork. Accordingly, I'm trying to find compliance software that makes sense for our system. We're doing small manufacturing of a Class I device, so I don't need anything complicated, but it seems that there are thousands of options out there.

Does anyone have any experience with particular paperless compliance software? I'd love to keep the whole thing completely paperless, which means I'd only be interested in something with 21 CFR 11-compliant electronic signature and document control capabilities.

I'm reluctant to buy before trying, but I also don't want to spend months going through free trial after free trial. Any information you could provide from your own experience or recommendations of reviewers would be great.

By the way, we may be moving in a CE-marked product in the future, so something that works with MDD stuff would be great. If you can point me to something that's also suitable to JPAL compliance, I'd love it. I suppose all of that could be addressed by a company that's good with customizing their default software based on customer requirements.

Thanks in advance!

Click to expand...

We recommend EtQ...

hi friend,

i'm from indonesia, we have experience with paperless documentation, we create documentation with windows server and any variation and improvisation

if you need software, please check alfresco, that's powerfull paperless documentation with the feature, electronic sign, etc, you may choice any package that's offer

pls try it


thanks
kokok

Welcome to the Cove, asfharrison and kokok

kokok_sn said:

hi friend,

i'm from indonesia, we have experience with paperless documentation, we create documentation with windows server and any variation and improvisation

if you need software, please check alfresco, that's powerfull paperless documentation with the feature, electronic sign, etc, you may choice any package that's offer

pls try it


thanks
kokok

Click to expand...

Hi Kokok and welcome to Elsmar

Do you know by any chance if Alfresco is Part 11 Compliant?

Alberto

A note to those who are following this thread or may come across it during a search: beware of claims of compliance to Part 11. Many software manufacturers make this claim and some even sell packages that will 'help you to validate' your software purchase. In my limited experience, I've found that these claims are based on very thin evidence (or no evidence) and your individual installation, configuration, and any customization may negate any such claim. Do your homework before making an expensive mistake.

Regards,

Kevin

Kevin Mader said:

A note to those who are following this thread or may come across it during a search: beware of claims of compliance to Part 11. Many software manufacturers make this claim and some even sell packages that will 'help you to validate' your software purchase. In my limited experience, I've found that these claims are based on very thin evidence (or no evidence) and your individual installation, configuration, and any customization may negate any such claim. Do your homework before making an expensive mistake.

Regards,

Kevin

Click to expand...

Do these companies tend to have a problem with letting you verify part 11 compliance? It seems that any failure to comply with part 11 should be relatively easy to correct (the requirements seem pretty simple), but I'm not a programmer. Also, if you buy (at least in part) on the basis of part 11 compliance, and that's obvious from the company's advertising or your communication with them, can't you force them to indemnify you for costs arising from their failure to meet the standard? I suppose that's a big headache. Suing always seems so much easier than it is.

Particularly, do you know of any companies that are known to be prickly or hard to deal with about this? It would be good to know so that we can avoid the hassle in the first place.

Thanks to everyone for all of the feedback so far.

ASF,

I should clarify in that when I ran into the most recent issue (about 4 or 5 years ago), the calibration tracking software provider was claiming compliance to Part 11 and offered a validation package as a companion purchase. Our biggest issues was getting the software to do what it said it was supposed to do and proceeded to find several bugs. Records for one device would come up for another, date stamps were wrong, and records could be overwritten during some negative scenario testing. The provider was generally nice for about 4 months after the purchase. Many of our finds found their way into the next version software and they provided us with free upgrades. We continued to find bugs for about another 8 months before we finally abandoned it for the PM module in SAP.

To your point, the software purchase was the least expensive item really. Developing local requirements and planning for the project, creating and executing the validation documentation, and completing interim and final summaries was far more costly. I think that when I explained this point to the salesman, he got us the first of the three version upgrades. I suppose that the free upgrades plus another free seat kept me from thinking about suing them. In the end, I took it for a learning lesson. The departure from their software was really a decision made by the corporate office in an unrelated move, so we only lived with compliance issue temporarily.


Regards,

Kevin

asfharrison said:

It seems that any failure to comply with part 11 should be relatively easy to correct (the requirements seem pretty simple), but I'm not a programmer.

Click to expand...

Not at all! If the infrastructure doesn't exist to support audit trails and the like, it is by NO means easy to correct - and would not likely be correctable in software. So indeed, do your homework before buying.

We had a client that used ISO Achiever. When we first started working with them, they were not Part 11 compliant and I had my doubts that the software could support them. But they worked with the vendor to better understand the capabilities and eventually we were able to get through it.