Audits don't announce themselves. But you can.
AuditCheck runs a weekly/monthly compliance readiness check across your operations.
Get a real-time score and know exactly what needs fixing before regulators arrive.
How It WorksYou don't know if you're audit-ready until inspectors arrive.
You don't know if you'd pass a surprise FDA inspection tomorrow. When auditors arrive, you discover critical gaps.
Unplanned audits shut down operations for days. Remediation costs thousands. A failed audit can suspend your license.
Veeva costs €500k+/year and takes 6 months to implement. Mid-size manufacturers need a simpler solution.
Weekly/monthly audit readiness checks. Real-time compliance scores.
AuditCheck runs a 10-step compliance check across your organization using the COMPLIANCE framework.
Know exactly where you stand: 87% audit-ready this week. Green/Yellow/Red status. What's working. What needs attention.
See exactly what needs fixing: who's responsible, and by when. Not just a score—a roadmap for your team.
The 10-step assessment that measures your audit readiness:
If an audit was announced tomorrow, who would call who first? Is that documented?
If I asked you to find all records from January 2025 right now, how long would it take?
Are all instruments and equipment validated and currently calibrated?
Are your SOPs written, approved, and current? Can your team access them?
Are all changes to records tracked, dated, and attributable to who made them?
If you find a compliance gap, how quickly can your team fix it?
Is staff training documented and current? Does your team know their compliance responsibilities?
How do you document and track compliance issues? Is there a closure process?
When something goes wrong, do you have a documented process to fix it and prevent recurrence?
Who has visibility into compliance status? Is there executive oversight?
Scoring: ✓ Green (fully compliant, 1–2 week fix) • ◐ Yellow (partially compliant, 2–4 week fix) • ◉ Red (non-compliant, 1+ month to fix)
You know, every week, if you'd pass a surprise inspection. No more guessing.
Scheduled audits? You're prepared. Surprise inspections? You pass. No scrambling.
Know your readiness status year-round. Not just before audits—every day.
The readiness gap: between enterprise systems and chaos.
FDA-regulated manufacturers have two choices: Enterprise QMS (€500k+/year, 6-month implementation) or spreadsheets and prayers. There's no middle ground. Until now.
Pharma & biotech manufacturers (20–500 employees). Medical device manufacturers. Food manufacturers. Anyone with FDA/EMA/HPRA compliance requirements.
Mid-size manufacturers make up 60% of regulated production but lack enterprise tools. They need audit readiness—not documentation management.
Built by someone who lived both sides of this problem.
6 years as a cell culture biologist at major pharma companies—lived the compliance scramble first-hand. Watched teams hunt for batch records before audits. Saw how paper trails break under pressure.
8 years as a software engineer—built the technical expertise to solve it. Understands both the regulatory requirements and the product architecture needed.
TechStars Women Startup 2026 participant. Currently building AuditCheck full-time, backed by contracting work and initial customer validation.
Validating audit readiness as a product category.
We've spoken with QA managers at FDA-regulated manufacturers. The feedback is clear: "If we could know we're audit-ready every day, that would change everything."
We're looking for: (1) Early pilot customers (2–3 manufacturers willing to test our readiness assessment), (2) Introductions to QA/compliance leaders at mid-size pharma and biotech, (3) NDRC Pre-Accelerator support to accelerate customer validation and product development.
This is the gap between enterprise systems and chaos. We're filling it.
Get in touch to discuss how AuditCheck can transform compliance at your organization.
Questions, partnership interest, or customer pilot conversations—let's connect.