Is AI Tech Secure validated for 21 CFR Part 11?
The Pharma GxP Assurance pack includes e-signature attestation, IQ/OQ/PQ validation records, immutable audit chains, and change freeze for regulated environments.
Problems We Solve
From Pain to Platform Outcomes
Challenge: Audit evidence scattered across tools
AI Tech Secure: Unified compliance reports and export catalog
Challenge: Pharma validation requirements
AI Tech Secure: IQ/OQ/PQ validation records and GxP Assurance wizard
Challenge: External auditors need read-only access
AI Tech Secure: Grant-scoped Big 4 auditor portal
Challenge: Immutable audit trail required
AI Tech Secure: Verify and export audit chain integrity
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Compliance Reports
SOX, GDPR, ISO 27001, PCI DSS, SOC 2, GxP, and FDA 21 CFR Part 11 compliance reporting with remediation tracking and executive dashboards.
Get Demo āKey Capabilities
āMulti-framework compliance engine
āSOX, GDPR, HIPAA, PCI exports
āISO 27001 and NIST reports
āRemediation tracking
āCompliance score trending
āExecutive PDF export
Key Capabilities
āIQ/OQ/PQ validation records
ā21 CFR Part 11 e-signatures
āChange freeze capability
āGxP go-live checklist
āOQ probes and validation mode
āImmutable audit chain
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Pharma GxP Assurance
IQ/OQ/PQ validation records, e-signature attestation, change freeze, and go-live checklist designed for regulated SaaS and on-premises deployments.
Get Demo āš
External Auditor Portal
Read-only, grant-scoped Big 4 auditor access ā no configuration changes, with visibility into campaigns, findings, evidence, and approvals.
Get Demo āKey Capabilities
āGrant-scoped auditor access
āRead-only portal
āGxP audit pack ZIP export
āCampaign and finding visibility
āEvidence download
āNo config change permissions
How It Integrates
Connector Factory ā Module ā IGA Warehouse
Every module pulls fine-grained ERP permissions through the Connector Factory and writes outcomes back to the unified identity warehouse for certification, SoD, and audit evidence.
ORCHESTRATION
Connector Factory
MODULE
Compliance & Pharma GxP
UNIFIED DATA
IGA Warehouse
š Outcomes
Measurable Results from Day One
98%+
Compliance Scores
1-Click
Audit Pack Export
21 CFR
Part 11 Ready
Zero
Audit Scramble
š Integrations
P2P Controls
O2C Controls
PAM
IGA
Database Security
GxP Assurance Pack
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Common Use Cases
āFDA inspection readiness
āSOX ITGC evidence collection
ā21 CFR Part 11 access control
āHIPAA access governance
āBig 4 external audit support
āGxP validation documentation
FAQ
Frequently Asked Questions
Can external auditors get read-only access?
Yes. The External Auditor Portal provides grant-scoped Big 4 read-only visibility into campaigns, findings, and evidence without configuration changes.
Which compliance frameworks are supported?
SOX, GDPR, ISO 27001, PCI DSS, SOC 2, GxP, HIPAA, and FDA 21 CFR Part 11 with exportable evidence packs.
Related products
Stay Audit-Ready ā Book a Demo
Book a personalised demo tailored to your ERP landscape and audit goals.