Built for Regulated Materials From the Ground Up
GXP-Guardianยฎ is not a warehouse management system with a reporting module. It is not a LIMS with a storage add-on. It is the first digital-native platform purpose built to consolidate regulated physical and electronic records material and harmonize all related data into a single regulatory-compliant platform.
The result: Smashed silos. Continuous compliance. Optimized costs. Simplified research and manufacturing. Immutable chain-of-custody. AI-powered insight.
One Platform. One Federated View. Audit-Ready by Design.
Silos Eliminated. Value Unlocked.
GXP-Guardian solves fragmentation at the system level, working simultaneously on your physical material and related electronic records data. Here are the ways that translates to operational value:
End-to-end, inspection-ready chain of custody. One immutable chain-of-custody from receipt through final disposition โ defensible in any regulatory inspection.
Unified, analytics-ready data foundation. One AI-ready system of record, standardized across every source โ the data foundation your analytics strategy requires.
Real-time, network-wide inventory visibility. Real-time inventory visibility across every site, every status, every geography โ eliminate duplication and waste.
Automated, event-driven retention management. Automated lifecycle intelligence tied to regulatory event โ disposition when the obligation is met, never before and never years after.
Instant, audit-ready documentation access.
Audit-ready documentation generated in seconds โ complete chain-of-custody, temperature records, QC history, in one interface.
Your Data. Every Source. One Governed System.
GXP-Guardian is not a passive repository. It has the ability to actively import study and manufacturing data from your existing systems, harmonize it into a single validated schema, and control exactly who can see what. It has the ability to actively import study and manufacturing data from your existing systems, harmonize it into a single validated schema, and control exactly who can see what.
That foundation creates a fundamentally different operational posture: one audit-ready system of record, one continuous chain-of-custody, and one federated view across every geography where your materials are held โ all within a platform that scales with your programs from pre-clinical specimens to clinical trials, manufacturing materials, and healthcare archives to optimize costs, simplify compliance, and accelerate research.
The First & Only Platform Engineered Exclusively for Regulated Material Lifecycle Management
Import & Harmonize
GXP-Guardian accepts study and manufacturing data from key source systems and format categories. On import, every dataset is mapped to the GXP-Guardian unified metadata schema: field standardization, nomenclature normalization, and discrepancy flagging happen automatically at ingest โ without manual re-entry, without version conflicts, and with full source data lineage preserved for audit purposes.
Capture Every Access Event - Every Time
Login. Material view. Record download. Status change. Electronic signature. API call. Every interaction with GXP-Guardian โ by any account role, from any device, in any geography โ is captured in the immutable audit trail: who accessed what, when, from where, and what they did.
Control Visibility Through Account Roles & Permissions
A federated view of regulated material is only as valuable as its access controls are airtight. GXP-Guardian applies role-based access control (RBAC) at every level of the platform โ ensuring that each user sees exactly what they are authorized to see and nothing more. Visibility is controlled at the account level, the organizational level, the program level, the site level, and the geographic level simultaneously.
Capabilities That No General-Purpose System Can Replicate.
GXP-Guardian aggregates your physical sample inventory and harmonizes the related electronic records data โ CRO LIMS exports, lab manifests, QC records, retention schedules, chain-of-custody documentation โ from every source into a single regulatory-compliant platform. Whether materials are held at our American or UK sites, you see one harmonized, audit-ready research library in a single interface.
Real-Time Inventory Status
Quarantined/Approved/Rejected/ Released โ role-based access, and automated alerts. Every status change generates an immutable audit trail record. Never lose sight of a material’s status.
Data Import & System Integration
Import study and manufacturing data directly from ERP systems, LIMS platforms, QMS tools, and CRO systems. Native connectors eliminate manual re-entry. Imported data is harmonized to GXP-Guardianโs unified schema on ingest โ clean, validated, and immediately audit-ready.
Lifecycle & Retention Intelligence
Retention schedules tied to regulatory or business requirements, not contract renewal. GXP-Guardian monitors obligations by study, batch, and patient status โ alerting you when materials approach their horizon and presenting compliant disposition options.ย
Immutable Chain-of-Custody
Every movement, every record update is tamper-proof, multi-factor-authenticated, and timestamp-verified and includes defensible chain-of-custody from first receipt through final disposition โ no gaps, no resets.
GXP-Guardian: One Federated, Multi-Site View of Your Entire Regulated Collection
Defragment your legacy research once. Maintain best practice going forward โ across every program, every site, every geography.
To learn about GXP-Guardian, download our information sheet.