Seal

Seal develops a unified GxP execution platform designed for regulated life sciences companies. The platform covers a broad range of operational and quality functions — including ELN, LIMS, MES, QMS, inventory management, clinical trial management, and more — within a single AI-configured system. Seal positions itself as a replacement for fragmented point solutions, with a stated deployment target of going live within 48 hours. The platform is validated for use in GMP, GLP, and GCP environments and is used by more than 50 regulated companies.

Customers using Seal have reported outcomes including a 10× improvement in traveler review speed (Paradromics), a 40% reduction in non-conformances (Skye Biologics), 2× faster quality cycles (Acclinate), full data traceability (Bioventix), and lot genealogy retrieval in seconds (MiAlgae).

Core Modules and Blueprints

• Manufacturing Execution System (MES): Captures batch records as manufacturing runs. Workflows are AI-configured and evolve with the process. Unified with LIMS, QMS, and ELN.
• Quality Management System (QMS): Delivers quality events with full contextual information. AI-configured workflows that adapt over time. Unified with MES, LIMS, and ELN.
• QC LIMS: Designed to clear batches in days rather than weeks. Methods evolve with the process and are unified with 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 (ELN): Captures experiments as structured data. Methods flow directly into LIMS, MES, and QMS, connecting discovery through to batch release.
• Inventory Management: Provides container-level tracking with status enforcement, aimed at preventing stockouts, expired-material deviations, and inventory uncertainty.

Additional Functional Areas Covered

• Batch Master Records (BMR) and Batch Release
• Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF)
• Document Control and Change Control
• CAPA and Deviations management
• Stability and Environmental Monitoring
• Equipment and CMMS (Computerized Maintenance Management)
• Design Controls and Regulatory Submissions
• Electronic Data Capture (EDC) and Biobanking
• Training and Audits management
• Supplier Quality and Labeling
• Sample Management and Warehouse Management System (WMS)
• Weigh and Dispense, Certificate of Analysis (CoA), and SDMS
• Complaints, Chemical Safety, and Regulatory Information Management (RIMS)
• Process Validation, Audit Readiness, and Automated Reporting
• CMC, ATP, VDMS, and LMS

Platform Characteristics

• AI-configured workflows that adapt as processes evolve, reducing the need for manual reconfiguration.
• Pre-configured GxP system blueprints validated across GMP, GLP, and GCP regulatory frameworks.
• Unified data architecture connecting ELN, LIMS, MES, and QMS to provide end-to-end traceability from discovery through release.
• Rapid deployment model with a stated go-live timeline of 48 hours.
• Trusted by more than 50 regulated companies across the life sciences sector.