Solutions›Compliance & Quality

Inspection-ready. Every day, not just audit day.

Automate signal detection, audit trails, and GxP documentation so compliance isn't a bottleneck. AI agents monitor continuously — not just when the auditor calls.

Talk to our compliance team

Our perspective

Compliance teams are drowning in documentation, not decisions.

GxP compliance in pharma is an exercise in documentation management. Teams spend 60–70% of their time maintaining audit trails, updating SOPs, tracking training records, and preparing for inspections.

Zelthy automates the documentation layer entirely. Every action generates an audit trail. AI agents detect compliance gaps in real time, flag adverse event patterns, and keep inspection packages current.

The compliance lifecycle

From policy to proof. Continuously.

Compliance isn't an event — it's a continuous loop. Every step feeds the next, and gaps anywhere create findings everywhere.

Policies and SOPs are the foundation — if anyone can find them

Every GxP-regulated operation starts with documented policies, SOPs, and work instructions. But the lifecycle of these documents — authoring, review, approval, distribution, training, retirement — is itself a compliance burden that most organisations manage poorly.

Without a platform

SOPs in shared drives with unclear version control. Review cycles missed. Distribution untracked. No proof that the right people read the right version.

With Zelthy

Full SOP lifecycle management — authoring, review, approval, controlled distribution, and acknowledgement tracking. AI agents flag SOPs due for periodic review. Automated training assignment when SOPs change.

From gap assessment to continuous compliance

Always inspection-ready. Not just on audit day.

Compliance engagements start with your current documentation reality: assess gaps, deploy automated audit trails and monitoring, continuously improve based on real compliance data, and transfer ownership to your quality team.

Your compliance gaps. Your regulatory landscape.

Every compliance deployment starts with understanding your current documentation reality — what's manual, what's missing, where inspections have flagged issues. Zelthy works with your quality and compliance teams to map GxP requirements, audit trail gaps, SOP lifecycle issues, and pharmacovigilance workflows against your specific regulatory obligations.

Outcome

Complete compliance gap assessment with prioritised remediation roadmap

Timeline

1–2 weeks

100%

audit coverage

70%

less manual documentation

Real-time

signal detection

4-8 wks

to deployment

Proof

Proven in regulated environments.

Compliance · Multi-marketMulti-market

Read the full story →

A global pharma company's quality team was spending 60% of their time preparing for inspections — assembling audit packages manually from five different systems.

100% audit trail coverage70% less manual documentationReal-time gap detection6-week deployment

Use Cases

Everything we can deploy for Compliance & Quality.

Compliance Monitoring & Risk

Cross-system surveillance — risk scoring, policy enforcement, exception detection, auto-remediation.

Global PSP Compliance

Multi-country compliance — consent management, AE detection, cross-border data governance.

Compliance Co-Pilot

AI assistant — regulatory Q&A grounded in your SOPs, document scoring, SOP drafting, policy gap analysis.

Events Compliance

HCP spend monitoring, Sunshine Act/EFPIA classification, hospitality limits, transparency reporting.

Promotional Review (PRC/MLR)

AI-powered content review — claims validation, fair balance, reference verification, PRC/MLR workflow.

Third-Party Due Diligence

FCPA/anti-bribery — risk profiling, media screening, questionnaires, ongoing monitoring.

Clinical Trial Transparency

Registry submissions, results posting — ClinicalTrials.gov, EU CTR — deadline tracking.

Code of Conduct & Ethics

Whistleblower intake, complaint triage, investigation workflows, compliance culture measurement.

Compassionate Access

Expanded access — request intake, medical review, ethics approval, regulatory filing, logistics.

Pharmacovigilance & AE Management

Adverse event lifecycle — intake, assessment, reporting, signal detection, regulatory submission.

Explore use cases across all verticals

Ready to stop preparing for audits?

Talk to our compliance team. We'll show you how continuous monitoring replaces last-minute audit preparation.

Talk to our compliance team