Seal GxP Execution System

Seal GxP Execution System is a single AI-configured platform designed for regulated life sciences organisations operating under GMP, GLP, and GCP requirements. It consolidates functions across ELN, Inventory, LIMS, MES, QMS, and Clinical into one unified system, with the stated capability to go live within 48 hours of deployment.

The platform is used by 50+ regulated companies and is structured around pre-configured workflow blueprints that can evolve alongside a team's processes. Reported outcomes from customers include 10× faster traveler review, 40% reduction in non-conformances, 2× faster quality cycles, 100% data traceability, and lot genealogy retrieval in seconds.

Supported Modules and Functional Areas

• Quality Management System (QMS)
• Manufacturing Execution System (MES)
• Laboratory Information Management System (LIMS)
• Electronic Lab Notebook (ELN)
• Inventory Management
• Tech Transfer
• Batch Master Records (BMR)
• Clinical Trial Management System (CTMS)
• Document Control
• Stability Management
• CAPA and Deviations
• Equipment and CMMS
• eTMF and SDMS
• Design Controls and Change Control
• Certificate of Analysis (CoA)
• Electronic Data Capture (EDC)
• Biobanking and Sample Management
• Training and Audits
• Warehouse Management System (WMS)
• Supplier Quality and Labeling
• Environmental Monitoring
• Complaints and Weigh & Dispense
• Regulatory Information Management (RIMS) and Regulatory Submissions
• CMC, ATP, VDMS, LMS
• Batch Release and Audit Readiness
• Process Validation and Automated Reporting
• Chemical Safety

Pre-Configured Blueprints

• Manufacturing Execution System: Captures batch data as manufacturing runs, with AI-configured workflows that integrate with LIMS, QMS, and ELN.
• Quality Management System: Delivers quality events with full context attached, using AI-configured workflows unified with MES, LIMS, and ELN.
• QC LIMS: Supports batch clearance in days rather than weeks, with methods that evolve with the process and integration across MES, QMS, and ELN.
• Tech Transfer: Carries process definitions forward from development to GMP and across sites as structured, version-controlled assets, eliminating manual re-entry.
• Electronic Lab Notebook: Captures experiments as structured data, with methods flowing directly to LIMS, MES, and QMS from discovery through to release.
• Inventory Management: Provides container-level tracking with status enforcement to prevent stockouts, expired-material deviations, and untracked stock.

Platform Characteristics

• AI-configured workflows that adapt as processes change over time.
• Validated for use in GMP, GLP, and GCP regulated environments.
• Unified data model connecting ELN, LIMS, MES, and QMS to support traceability across the full product lifecycle.
• Deployment target of 48 hours to go live.

Seal is positioned for regulated life sciences organisations that require cross-functional GxP coverage without operating multiple disconnected systems. The platform's blueprint approach allows organisations to adopt pre-validated configurations for specific workflows while maintaining the ability to extend and evolve those configurations over time.