Pharmaceutical Security Solutions

Overview

SpiAlert delivers pharmaceutical-specific cybersecurity solutions that ensure regulatory compliance while protecting valuable research data and manufacturing processes. Our continuous verification approach meets stringent FDA requirements while enabling efficient operations across your entire pharmaceutical enterprise.

Pharmaceutical organizations face strict regulatory requirements and security challenges. Our solutions provide GxP compliance, data integrity protection, and FDA 21 CFR Part 11 support while maintaining the agility needed for research and development.

Key Capabilities

• •GxP Compliance & Data Integrity Protection
• •Clinical Trial Data Access Control
• •Laboratory Information Management System (LIMS) Security
• •Clean Room Access Verification
• •Research & Development IP Protection
• •FDA 21 CFR Part 11 Compliance Support
• •Batch Record Authentication & E-Signatures
• •Quality Control System Access Management
• •Vendor & CRO Access Monitoring
• •Drug Manufacturing Execution System (MES) Protection

Why Choose SpiAlert for Pharma?

• ✓FDA-Ready: Built with 21 CFR Part 11 requirements in mind
• ✓Data Integrity: Ensures audit trails and non-repudiation for compliance
• ✓Zero Compromise: No impact on R&D or manufacturing efficiency
• ✓Regulatory Support: Maintains compliance documentation automatically