Every cross-reference checked.Every inconsistency surfaced.
Built for GxP consultants. AuditReady traces the dependencies between your client's documents and flags where the story breaks down — before an auditor does.
The problem
The Cross-Reference Problem
You know where 483s come from. The question is whether you can trace every dependency before the auditor does.
The SOP cascade
SOP-2847 gets revised. Now every training record, form, and batch procedure that references it needs updating. Tracing that full cascade across a live QMS is where gaps form.
Revision mismatches and stale references
Training record cites Rev 3.1, current SOP is 4.2. Stability data doesn’t support the shelf-life claim. The CAPA closed but the deviation wasn’t linked. These are the cross-reference failures that become 483 observations.
The narrative has to hold under scrutiny
The auditor checks if training was completed before the batch was released, if the validation report supports the process parameters, if the CoA was current at time of use. Every document has to tell the same story.
Form 483s issued by FDA in FY2024
Documentation gaps and inconsistencies
Downstream documents affected by a single SOP change
How it works
Your expertise + AI cross-referencing
You bring the judgment. AuditReady traces every dependency and flags where the narrative breaks down.
Upload the audit package
The documents your client is preparing for inspection. SOPs, training records, batch records, stability reports — everything that needs to tell a consistent story.
AI traces every cross-reference
AuditReady maps the dependencies between documents and flags where references are outdated, where data doesn’t match claims, and where the narrative breaks down.
You review the flagged issues
Prioritized findings with context. You decide what matters, advise on risk, and help your client tell a coherent, defensible story to the auditor.
Why AuditReady
A better offering for your clients
Catches what cross-referencing catches
The same inconsistencies an auditor would find by tracing document dependencies. But across the entire document set, systematically.
Keeps the narrative coherent
Claims match data. Revisions are aligned. Training records reference the right procedures. The story holds up under scrutiny.
A premium service you can charge for
Comprehensive cross-reference analysis is something manual review can’t match. It’s a new tier of service — priced accordingly.
Your expertise stays at the center
AI flags the issues. You interpret them, assess the risk, and coach the team on how to respond. The judgment is yours.
Who it's for
Built for GxP consultants
Whether you're independent or part of a firm — if you prepare companies for regulatory inspections, AuditReady is built for you.
Offer your clients a level of coverage that used to require a full team. Your expertise plus AI-backed analysis.
Deliver comprehensive audit preparation without scaling headcount. Full document coverage on every engagement.
Go deeper on pre-inspection work. Surface findings across the full document set, not just the sample you can review manually.
The team
Based in Zurich
AI infrastructure expertise from Google, medical research from Harvard and DKFZ — building the document intelligence layer that GxP compliance has been missing.
Kolja Esders
Former Google Senior Engineer and Tech Lead. Now applying large-scale ML infrastructure to regulatory document analysis.
Alexander Haas
Medical doctorate in Computational Oncology from Harvard Medical School and DKFZ. Bridges the gap between clinical science and the regulatory frameworks that govern it.
Eskil Jarlskog
Former Google Engineer specializing in LLMs and Generative AI. Building the document understanding engine that powers AuditReady’s cross-reference analysis.
Get early access to AuditReady
Be the first to offer your clients comprehensive cross-reference analysis on every engagement.