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.
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