Regulatory compliance software to reduce audit risk
and protect market access
Challenge
Growing life science companies face rising compliance complexity across products, markets and overlapping regulations.
Manual, reactive processes, spreadsheets, siloed tools and consultant-led audits cannot keep pace with frequent release cycles or multi-jurisdiction requirements.
The result is slower launches, higher costs, and increased exposure to findings and delays.
Solution
Qualio's Compliance Intelligence automates multi-framework gap analysis, centralizes evidence and continuously monitors your compliance posture to keep you constantly audit-ready.
Explainable AI surfaces risks with audit-ready traceability, then guides remediation to closure.
You get faster approvals, fewer surprises, and real-time executive visibility across every product and market.
Compliance audit software that gets you audit-ready in weeks, not months
- Automated gap analysis in ~30–40 minutes highlights prioritized risks and actions
- Audit prep reduced from 20–24 weeks to about 4 weeks
- Market expansion readiness reduced from 9 months to about 3–4 months
- Avoid delays from missing or incomplete evidence and keep investor confidence high
Eliminate audit surprises and reduce penalties exposure
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Continuous dashboards and alerts catch issues before auditors do
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Explainable AI with full audit trails for internal and external inspections
- Close gaps earlier to reduce costly CAPAs, enforcement actions and recall exposure
Do more with the team you have
- Remove hundreds of hours of manual evidence gathering and mapping
- Automate remediation with delegated workflows and CAPA generation
- Reduce external consultant spend by $150K–$300K per year
One platform for multi-standard confidence and lower total cost
- Pre-validated frameworks for ISO 13485, IEC 62304, ICH Q10, the FDA QMSR, EU Annex 11 and more
- Evidence reuse across audits and markets avoids duplicate work
- Executive dashboards provide a single source of truth for board-ready reporting
- Reduce tool sprawl and services by consolidating QMS-adjacent compliance activities
How our compliance management software works
1. Connect and ingest your documents and evidence
2. See your risk map and prioritized actions in minutes
3. Remediate and monitor with guided workflows and alerts
Explainable AI + audit trails
Recommendations are traceable and regulator-ready
Continuous monitoring
Always-on compliance health across frameworks
Evidence reuse
Map once; reuse across submissions and audits
Deep integrations
Jira, GitHub, Azure DevOps, document systems, QMS artifacts
Purpose-built for life sciences
Frameworks authored by domain experts with decades of industry experience
Executive visibility
One source of truth for leadership and the board
Learn more about our regulatory compliance software
Compliance Intelligence one-pager
Grab a shareable overview of our compliance software
Don't just take our word for it!
Hear from the companies already using our compliance management software
“A game changer for all those who have to manage integrated management systems.”
Quality manager
Digital health leader
“What used to take months now takes weeks.
Compliance Intelligence gave us a prioritized risk map in under an hour and we walked into the audit with zero surprises.”
VP of Quality & Regulatory
Medtech company
“I was able to actually identify gaps that I wasn't aware of, then trigger actions that will be beneficial for us to improve our compliance.”
Quality & regulatory leader
SaMD company
“I wish I'd had Compliance Intelligence when I was starting my QMS.
It would have doubled our onboarding speed.”
Quality & regulatory leader
Biotech manufacturer