Software recommendations for CAPA that will meet the FDA QSR & Part 11

C

cspofford1

#1
We are investigating a CAPA software solution -- unfortunately, every time we have started this investigation, the quotations we receive from companies start out over $100K. These quotations are always for lot of users and I guess for larger companies.

We have a total of 140 people and would probably only need to have 5 concurrent licenses to start for this solution. What we are interested in is a scaleable solution that as we grow that we can add more licenses.

Do you have any recommendations of software solutions for CAPA that will meet the FDA QSR & Part 11 requirements?

Thanks for your help!
 
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CarolX

Super Moderator
Super Moderator
#2
I retitled your thread and moved it to this board - hoping to get some answers.

Sorry I have not recomendations, but perhaps someone can make some suggestion.
 
N

nise_nin

#3
For an area like CAPA, it can not successfully work if you are tied to user licencing. CAR's, should be able to be submitted by potentially any company employee, and depending upon the corrective action required, could be routed to any dept for the C.A. The goal of any automated QMS system (I believe) is to make less administrative work for the QA/QM dept, not more. If the "software" is used as a "tool for the QA/QM dept", and not a company wide process driven system, then it will have limited success, and potentially create more work for the QA/QM dept than with a manual based system!

But that does bring up the valid point of pricing, currently in the market due the critical mass (or lack there of) of customers requiring solutions for QM, hence such solutions are quite expensive. In every company budget is a significant driving factor, but my suggestion is for CAPA (other quality areas are different), is that an company wide system is the best approach, local "database" or desktop software for CAR's (USD1,000-5,000) are available, for CAR submissions maintained by QA/QM can involve significant work by this dept but only providing limited value in return. So the challage is to find one that meets your budget (sales pitch ;-) here ). Our solution is certainly not in the hundreds of thousands and can provide more information upon request.


Kind Regards

David
 
Last edited by a moderator:

Jim Ivey

Grand Avenue Software
#4
We are investigating a CAPA software solution -- unfortunately, every time we have started this investigation, the quotations we receive from companies start out over $100K. These quotations are always for lot of users and I guess for larger companies.

We have a total of 140 people and would probably only need to have 5 concurrent licenses to start for this solution. What we are interested in is a scaleable solution that as we grow that we can add more licenses.

Do you have any recommendations of software solutions for CAPA that will meet the FDA QSR & Part 11 requirements?

Thanks for your help!
My reply is a few months late, but I was intrigued by a couple of comments that you made. I hope you've already found an economical solution to your problems. If not, feel free to contact me about my company's products (we develop and sell quality management software for FDA-regulated companies - see profile).

With the "scummy vendor" disclaimer out of the way, I just wanted to respond to your expressed concern.

While historically its been true that quality management software for FDA-regulated companies is overpriced (both in terms of up-front costs, and over the long-haul with repeated validation exercises), there are a number of recent trends that are aggressively attacking that model:

- One trend has been for new software packages to offer significantly lower pricing for small-to-medium-sized companies. This is based on a recognition that small companies grow into larger ones, and that a shared investment by both the customer and vendor up-front can result in shared gains down the road as the customer grows.

- A parallel, complimentary trend has been a shift toward subscription-based licensing, rather than a one-time purchase. This allows a company to make a relatively small investment initially, and start to see a return on that investment quickly. If a software package turns out not to meet their needs, the "sunken cost" associated with it is very small. If it turns out to be a good fit, they can continue the subscription, using a portion of that ROI to pay for the software.

- Another complimentary trend has been a shift toward modular software packages. In a similar manner to subscription-based licensing, this trend has allowed companies to initially invest in a single, well-known problem (in your case, the CAPA process), implement a solution, start to see a return on that investment, and then incrementally add other software modules to attack additional problems. Again, the company has the opportunity to invest the smallest amount of money necessary to attack the most critical pain point. If it's not successful, they're looking at a "sunken cost" of a few thousand dollars, instead of $100k. If it is successful, then they can proceed on to the next pain point.

All of these trends in the software industry together are starting to allow the enormous number of FDA-regulated startups to implement an automated quality system very early on, instead of waiting until they have a "critical mass" to justify what was traditionally an enormous expense. As a reference point <scummy vendor alert> a company with less than 200 employees would pay roughly $3000/year for one of our modules (CAPA, in your case), with follow-up modules added at discounted rates</scummy vendor alert>.

One additional cost-related item for a future discussion thread is the recent emphasis in the software development industry on quality-focused development processes that put the onus on the software vendor to tackle the majority of the validation process, rather than leaving that completely up to the customer, or charging them exorbitant fees for additional validation. In my opinion, this "hidden cost" associated with quality system software is the real curse in the industry, and is primarily responsible for most companies being 10-15 years behind other industries in the technology they employ to solve business problems.

Whew. That was a nice rant. I feel so empowered. :eek:

Anyway, I'm interested in hearing other takes on the original poster's pain. Also, if you actually never found a solution that fit your needs, feel free to contact us. If we're not a good fit, maybe we could point you in the right direction.

Take care.

Jim Ivey
 
E

ETYSUN

#5
Dear All,

I'm also a software vendor in the QSM sector.

One thing to further consider besides price is the readiness of the company seeking software. Transitioning from a paper-based process to electronic is definitely a mind-set change. There are many things that will be different; the best check before taking the plunge is to be sure your paper-based system is mature and well thought out. In that way, the requirements document that your software package selection will be based, is clear and complete.

Another consideration that hits the budget is idea of hidden costs. The cost of the software is a beginning point. You must also consider annual maintenance of licenseware; internal IT support costs; internal software development costs (for validations and modifications); training costs; and most importantly, if other ancillary software is needed. On the last point, for example, would another reporting tool be required; a piece of middleware; etc?

Personally, software solutions of this nature do not have to be as costly as it has been. New internet technology, the accessibility of open-source (free) software building blocks, and clarity of regulatory workflow (via time/experience to date) facilitated by harmonized standards, make the software design and execution easier.

Please feel free to contact me if there are any questions to my comments.

Best regards,
 
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