The Digital-Native Standard for Regulated Storage
GXP-Guardianยฎ gives you complete control of your regulated materialโreal-time visibility, immutable compliance, and AI-driven intelligence in one secure, audit-ready system. Turn storage from liability to advantageโand lead with confidence.
Born Digital. Built for Compliance. Engineered for Confidence.
Unlike retrofitted LIMS, WMS, or simple database or paper-based systems, GXP-Guardian was engineered from day one for regulated life sciences. Our 21 CFR Part 11 and GAMP 5 validated infrastructure ensures every material movement, every access event, and every audit trail meets the most demanding regulatory standards.
Immutable by Design. Certified by Regulation. 21 CFR Part 11 compliant with an immutable chain-of-custody that locks every action, and transfer into a single, auditable source of truth.
Smarter Oversight. Zero Surprises. AI-powered analytics can continuously predict and prevent compliance risks before they occurโstrengthening visibility, minimizing deviation, and reducing inspection-day stress.
Innovation That Never Stops. Compliance That Never Falters. Continuous innovation through multiple validated releases annually ensures your systems stay ahead of regulatory expectationsโscaling seamlessly from startup to global enterprise operations.
GXP-Guardian Certifications and Attestations
GXP-Guardian maintains a comprehensive set of compliance certifications, requirements, and attestations. If there are any questions regarding compliance of our validated system, contact us.
21 CFR Part 11
U.S. FDA Code of Federal Regulations requirements for electronic records and signatures.
GDPR
General Data Protection Regulation law for the privacy rights of individuals in the European Union.
HIPAA
U.S. Privacy requirements for personal health information held by covered entities.
SOC 2
Type II report covering Security, Availability, Integrity, Confidentiality, and Privacy.
Disaster Recovery & BCP
Business Continuity and Disaster Recovery.
ISO 27001
Compliance with specific information security and risk management requirements.
ISO 27017
Adherence with ISO/IEC 27002 Code of Practice controls for cloud services.
ISO 27018
Adherence with Code of Practice controls for protection of personal information.
CSA STAR
Registry of security and privacy controls for cloud computing offerings.
CyberGRX
CyberGRX assessments apply a dynamic and comprehensive approach to third party risk assessment.
U.S. Data Privacy Framework (DPF)
A framework for complying with EU, UK and Swiss privacy requirements.
External Security Assessments
Attestation of penetration tests and security assessments performed by third parties.
Privacy Verified Seal
Responsible data collection and processing practices consistent with regulatory expectations.
HITRUST
Comprehensive, flexible and efficient approach to regulatory compliance and risk management.
WCAG 2.1 AA
WCAG defines how to make web content more accessible to people with disabilities.
NEN 7510
Protecting health information for organizations in the Netherlands.
C5 (ISAE 3000)
ISAE 3000 Report on the Cloud Computing Compliance Controls Catalogue (C5).
CCCS Assessment
Canadian Centre for Cyber Security (CCCS) Assessment.
ASP/SaaS
Information Disclosure Certification System for organizations in Japan.
CS Gold Mark
CS Gold Mark certifies our security level to be equivalent to the ISO/IEC 27017 standard.
ISMAP
Japanese government program to assess and register cloud services that meet government security requirements.
EU Cloud Code of Conduct
Adherence with EU Cloud Code of Conduct, Verification-ID: 2022LVL02SCOPE3110 and 2022LVL02SCOPE3111.
Spain Esquema Nacional de Seguridad (ENS)
Security standards for servicing the Spanish Public Sector and government agencies.
APEC Certification for Processors and Controllers
Asia-Pacific Economic Cooperation Privacy Recognition for Processors Certification.
NHS DSPT
Online self-assessment tool for UK organizations.
IRAP
Security assessment for Australian government customers.
PrivacyMark
Privacy-centric certification for organizations in Japan.
HDS
Enables certified companies to host French personal health data.
Validated Environmental Monitoring. Precision You Can Prove.
Your materials deserve more than basic monitoring โ they deserve validated certainty. Our 24/7 environmental control system continuously tracks temperature and humidity, trending performance in real time to predict and prevent deviations before they occur. Every condition is logged and audit-ready, ensuring secure preservation and regulatory peace of mind.
From Reactive to Predictive. From Risk to Readiness.
GXP-Guardian doesnโt just track โ it anticipates, prevents, and protects. Its AI-powered intelligence can transform complex storage data into real-time insight, giving you surgical visibility and control that keeps you ahead of compliance risk and reputation harm.
From Reactive to Predictive: Intelligence by Design.
Built into GXP-Guardian, AI-ready analytics deliver continuous oversight and proactive insight โ turning monitoring into mastery and keeping your operation audit-ready, every day.
Strategic Inventory Optimization
Real-time analytics can deliver total custody and visibility, eliminating phantom inventory, duplicate orders, and waste. The result: leaner operations and measurable cost savings through intelligent control.
Accelerated Development Timelines
Phase transition analytics expose bottlenecks before they slow you downโenabling proactive resolution, continuous compliance, and inspection-ready milestones that keep your programs moving.
Measurable Results. Proven Advantage.
GXP-Guardian eliminates the hidden costs of fragmented storageโrestoring visibility, control, and compliance confidence across your entire operation.
Lower Costs
Real-time inventory intelligence cuts waste and prevents duplication.
Audit-Ready, Always
Automated documentation slashes prep time and inspection stress.
Zero Deviations
Immutable chain-of-custody and predictive analytics that can prevent compliance breaches before they occur.
Time Reclaimed
Automation replaces manual tracking, freeing your team to focus on research, manufacturing, and healthcare.
Cost reduction
through inventory optimization
Faster audit preparation
with automated documentation
Zero compliance
violations protecting
your reputation
Operational hoursย reclaimed
from manual tracking and reporting
When every dollar saved drives efficiency and every audit passed protects reputation, GXP-Guardian becomes more than a platform – its your strategic engine for compliant, cost-efficient, continuous progress.