AI
FICS Catalyst · AI Workbench
Catalyst observes running systems and workflows, then generates evidence-grounded drafts with citations to what it observed. It accelerates documentation and review across validation, quality, regulatory, and clinical operations while leaving every final decision with the user.
User Requirements Specification
Working draftThe system shall require a second authenticated approval before a study build is released to production.
↳ Grounded in 2 sources
The system shall record an immutable, time-stamped audit entry for every change to a controlled record.
↳ Grounded in 3 sources
The system shall prevent a user from approving a record they authored.
↳ Grounded in 1 source
How it works
From observation to approved record
Observe
Catalyst observes your running system, screen by screen.
Review the cited draft
Each statement comes cited to what Catalyst observed.
Approve
One attributable sign-off. The decision is yours.
Export
Send the approved document to your validated system of record.
Catalyst eliminates 80% of document creation work, while every validation decision remains with your experts.
Trust
Built to earn a reviewer's trust
Catalyst is a drafting tool, never the system of record.
Bring your own model keys
By default, inference runs on our managed infrastructure. Connect your own model keys to keep it in your cloud instead.
Observed on your machine
The desktop app observes your running system locally and uploads only the screens and text it needs to ground a draft. We never sit in line with your system's traffic.
Never the record
Catalyst holds a working copy and hands the approved draft to your validated system. The binding signature happens there.
Grounded, or it says so
Every statement cites what was observed. Anything ungrounded is flagged for you to verify, not hidden.
The threshold
Why accuracy matters
AI productivity isn't linear with accuracy. There's a threshold around 90%, and below it, the gain disappears.
70%
Industry RAG baseline
87 hidden errors
in a 289-req URS, and you can't tell which 87
No line is trustworthy without source-checking
Marginal productivity gain
Verification cost ≈ drafting cost
80%
Improved AI tools
58 hidden errors
Still unknown which 58, same problem
Defensive review; trust never settles
Modest, fragile gain
Erodes as each error is found
92%
Catalyst, above threshold
~23 flagged items
Catalyst tells you which, refuses to fabricate
Trust holds; reviewer effort narrows
Real, durable gain
Productivity savings actually stick
Below the threshold, AI saves drafting hours, and you spend them all on verification. Above it, trust holds and reviewer effort narrows to what Catalyst flags. The threshold is the feature.
Measured, not claimed
How Catalyst compares
Verified against expert ground truth, not unverified vendor claims.
92%
Grounding accuracy, verified
Industry: 75–85% (est.)
~7%
Factual error rate, verified
Industry: 10–25% (est.)
82%
Writing-quality score
Competitors: not published
Grounds on the running system
Multimodal evidence from live screens and text, not just uploaded documents.
Independent citation verification
A separate process re-checks every cited item. 92% agreement with an expert panel.
Knows when it doesn't know
Withholds output when evidence is thin, instead of guessing.
Catalyst metrics from a 103-case evaluation against human-expert ground truth. Industry estimates from published enterprise RAG benchmarks. No GxP validation AI vendor has published accuracy methodology or benchmark results as of June 2026.
The boundaries are the point
What FICS Catalyst does not do
Catalyst is a productivity layer, not a regulated system.
Does not make risk decisions
All risk assessments remain with your validation experts. Catalyst drafts; humans judge.
Does not replace your existing VLMS
Finalized artifacts flow into your existing validation systems of record. No rip-and-replace.
Does not sit in your GxP stack
Catalyst operates as a productivity tool. Your validated systems remain untouched.
Does not change your approval flow
Catalyst outputs match your existing templates and approval workflows. SOPs stay intact.
Your team keeps every decision. Catalyst just makes the drafting fast.
Let your experts focus on what only experts can do.
FICS Catalyst handles the drafting so your validation team can spend their time on judgment, risk, and review.