Everything your regulated team needs.
One platform.

Enterprise identity, multi-plant org & cryptographic license control

Centralized enterprise governance for multi-plant organizations: RBAC segregation of duties, unified single sign-on (SSO) across DMS, LMS, QMS, LIMS, BRM, and AuditLens, high-availability infrastructure health monitoring, automated audit log exploration, and tamper-proof offline cryptographic licensing.

Next-Gen GxP Document Management & In-Browser Collaborative Authoring

Enterprise Electronic Document Management System for pharmaceutical, biotech, and API manufacturers: in-browser real-time collaborative editing with track changes, copy-controlled pantograph print security, 21 CFR Part 11 electronic signatures, lifecycle workflows, training interlocks, and ALCOA+ audit trails deployed on high-availability private cloud or on-premise infrastructure.

22-Module Enterprise Paperless LIMS with Dynamic Formula Worksheets

Advanced Laboratory Information Management System (LIMS) for pharmaceutical QC, formulation, and sterile testing: visual mathematical calculation engine (KF, Assay, Dissolution), automated volumetric solution standardization (N1V1 = N2V2), 2-phase OOS/OOT investigation root-cause trees, ICH stability chamber management, cleanroom Grade A–D environmental monitoring, and direct bidirectional SAP / ERP integration.

GxP Competency & Role-Based SOP Training Management

Ensure plant-wide audit readiness with automated SOP version-linked curricula, digital reading checks, classroom and virtual training tracking, biometric/e-signature qualification records, and real-time floor clearance interlocks connected to manufacturing operations.

Enterprise Quality Management: Deviation, CAPA, Change Control & Audits

Govern end-to-end quality events with agility: automated 2-phase investigations, 5-Why and Ishikawa root-cause analysis, CAPA effectiveness tracking, risk-based change control, and customer complaint lifecycles directly unified with controlled documents and batch execution records.

Digital Batch Manufacturing Records (EBR) & Electronic Logbooks

Eliminate paper batch binders with step-by-step master formula execution, real-time line clearance enforcement, digital equipment logbooks, operator qualification validation gates, and QA review-by-exception for accelerated batch release.

Real-Time Compliance Gap Detection, Inspection Room Mode & Audit Lifecycle Platform

Revolutionary compliance intelligence for pharmaceutical operations: continuously monitors and detects data integrity gaps and compliance anomalies in real time across DMS, LIMS, LMS, QMS, and BRM; registers, schedules, and tracks internal, vendor, and regulatory audits; and provides a live Inspection Room Mode with one-click cryptographic PDF evidence dossier exports to eliminate US FDA 483 audit risks.

Real-Time GxP Operational & Compliance Analytics

Executive quality dashboards, batch lifecycle metrics, multi-plant compliance scorecards, and high-performance audit trail exploration powered by native real-time analytical indexing.

Enterprise Air-Gapped AI Assistant for Regulated Operations

Secure, permission-gated intelligence running entirely within your validated perimeter. Accelerate SOP authoring, deviation summaries, chromatography peak checks, and inspection queries without external data exposure or model training on your proprietary records.