AICA is a patent-pending AI-powered compliance auditing tool that analyzes all of your QMS documentation at machine speed. Learn more and get a demo at aica.thefdagroup.com.
Download our full pricing sheet here, and check out our interactive pricing calculator here.
Since we launched AICA earlier this year, the pricing question has obviously come up on nearly every demo. What does it cost, and how exactly does pricing work for an AI-powered compliance tool?
Eric Boyd, AICA’s product manager, answers that question in the video here. Read on for the details and grab our 2-page explainer PDF below and forecast pricing for yourself using our calculator. We’ve kept this simple!
New to AICA?
AICA (the Audit Intelligence Compliance Assistant) reviews QMS documentation such as policies, SOPs, and work instructions against the FDA (and soon other) regulations a team selects.
It currently covers 21 CFR Parts 11, 50, 54, 56, 58, 211, 312, 314, 320, and 600, with additional regulations in development. AICA flags potential nonconformances, each with a regulatory citation and a suggested corrective action, and a qualified Quality professional reviews every finding before the report is final.
Learn more at aica.thefdagroup.com.
Pricing is based on the pages you run through AICA
We priced AICA to be as customer-friendly as possible, which means no annual contract, no onboarding charge, and easy tailoring to your specific needs.
AICA is priced on usage. Every page of every QMS document you run through an analysis counts toward your usage, so a small supplier audit costs less than a QMS-wide internal audit. For planning, we estimate an average SOP at about 25 pages based on real-world SOPs.
What you pay per page depends on how you buy, and there are three simple plans. Very importantly, no plan locks you into an annual contract. We know how much of a barrier contracts can be, which is why we’ve avoided them entirely.
Here they are:
Core, Pro, and Enterprise
Core is pay-as-you-go.
You pay $5 for each page processed, billed monthly, with no upfront payment and no minimum spend. Core covers FDA regulations in 21 CFR and includes seats for five users and one admin, plus guided onboarding.
Pro is prepaid.
An upfront payment of $15,750 buys 3,750 pages at $4.20 per page, enough for roughly 150 SOPs. Pro adds unlimited seats and access to discounted page add-ons if you need more. It also includes five hours of FDA Group SME consulting time to review your report and plan remediation with an expert on our team. European and Canadian regulations are coming soon to Pro!
Enterprise is custom quoted.
If you don’t fit into Core or Pro, we work with you to set a per-page rate that fits the size of your QMS and your audit needs. Enterprise adds on-site deployment if you want or need it, early access to new features, and a rate lock, which means your rate never resets to $5 per page.
So far, most teams bringing AICA into their workflow are landing on Core or Pro. The feature differences are small, and the main distinction is how you pay. If you expect to process more than about 3,150 pages (roughly 125 SOPs), Pro costs less than Core. It’s really that simple.
Use our interactive pricing calculator to see how pricing flexes with pages.
When you have more than 150 SOPs
If you have quite a few SOPs, Pro customers can add pages in three block sizes, and the larger blocks cost less per page:
1,000 pages for $4,200 ($4.20 per page)
2,500 pages for $8,750 ($3.50 per page)
10,000 pages for $25,000 ($2.50 per page)
Two other add-ons are available: An additional active regulation is $1,200. A Flex Session is a 60-minute session with an FDA Group expert for $450, and it works on any plan, including Core.
No plan locks you into an annual contract. We’re very intentional about this! When a Pro package’s prepaid pages run low, email alerts go to your users and admins. Your access continues after they run out, and extra pages bill monthly at $5 each until you buy a new package.
If you’d rather set a hard ceiling, we can cap the pages your account can process.
Two recent examples that show pricing in action
Eric describes two clients he recently helped choose a package.
The first is a Quality leader whose main audit need falls under 21 CFR Part 820, which isn’t live in AICA yet. She still wanted to try the tool, so she started on Core with a batch of about 50 procedures audited against Part 11. With no upfront cost and no annual commitment, it was an easy yes. A batch that size runs about $6,250 and gives her real results to judge AICA by before Part 820 support arrives.
The second leads a team that wrote 300 Quality documents from scratch several years ago. Later audits turned up gaps, and he wants to find where else they’re hiding in the QMS. That volume points to Pro. The base package covers the first 150 or so documents, and add-on pages cover the rest at a lower rate than Core.
Let’s talk about what fits your use case
Every team is different, so we make sure to understand how you think you’ll use AICA and find the option that naturally fits. Getting from a first conversation to a completed analysis takes just three steps. It typically looks like this:
A brief consultation with us about your audit program and compliance goals.
A planning conversation about your upcoming audit schedule, who on your team needs access, and the package that fits.
A kickoff call where your team brings its first batch of documents and uploads them with us, so everyone leaves comfortable running the tool.
Have questions or want to get a demo?
The full pricing details are in our two-page AICA pricing explainer. See the model in action using our interactive calculator.
If you’re ready to start the conversation, visit aica.thefdagroup.com and fill out our demo form, or email Eric Boyd at eboyd@thefdagroup.com.
If you’re new to AICA, watch a quick recorded intro demo here:
Read our other guides on AICA and AI-powered compliance auditing:
Elsa, HALO, and AICA: Comparing the FDA’s AI Tools With Ours
Eric Boyd Introduces the Latest Version of AICA in 3 Minutes
AICA’s Security Architecture: What Your IT Team Needs to Know
AICA is Officially Live — Here’s Everything You Need to Know
You can find everything we’ve published on AICA here.
