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Provides a validated digital form for electronic data entry in regulated environments, featuring electronic signatures, automated Audit Trail, and native Active Directory integration.
Ensures ALCOA+ data integrity by eliminating paper/Excel and drastically reduces human transcription risks.
Includes real-time validation with logical checks to prevent Out of Specification (OOS) entries.
Offers real-time data availability for production, allowing immediate decision-making.
Accelerates batch release via Review-by-Exception and ensures total regulatory compliance for FDA/EMA inspections.
Implements guided, sequential workflows where operators cannot advance until the current task is correctly completed.
Includes mandatory fields to prevent empty values, instant logical validation, and integrated multimedia support (photos/videos).
Forces SOP compliance, preventing the skipping of critical steps.
Guarantees total data integrity (ALCOA+) and drastically reduces human errors by acting as a proactive quality filter.
Enables "Right-First-Time" execution, minimizing deviations and operational costs.
Provides real-time process visibility for both Production and Quality.
Ensures legal and regulatory security with a robust digital record for inspections.
Completely replaces paper with an integrated electronic manufacturing guide and bidirectional ERP connectivity.
Automates data consolidation (weights, IPC results, material movements) and performs instant dynamic calculations (reconciliations, batch yields).
Based on ISA-88 standards with full Audit Trail.
Provides total batch traceability (genealogy) from raw materials to finished products.
Ensures data integrity and contemporaneity (ALCOA+) while eliminating omissions and transcription errors between systems.
Enables real-time batch release (Review-by-Exception), highlighting deviations for rapid Quality review.
Increases operational efficiency and visibility while reducing non-conformity costs through "Right-First-Time" execution.
Ensures the facility is "Audit-Ready" at all times.
Centralizes manufacturing, calibration, and maintenance schedules, integrating MES and CMMS functions.
Uses constraint-based optimization for automated scheduling based on personnel and machine availability.
Offers flexible, multi-calendar views.
Provides a unified holistic vision, eliminating silos between departments.
Synchronizes workflows to ensure equipment is calibrated when needed and replaces manual planning with a validated digital tool.
Maximizes OEE by reducing bottlenecks and improves predictability for strategic decision-making.
Guarantees compliance by preventing processes from starting without correctly calibrated equipment.
Centralizes and unifies all production floor and laboratory data into a single validated platform (Single Source of Truth).
Includes global dashboards for real-time monitoring of process status, quality, and deviations.
Provides centralized historization and Audit Trail under ALCOA+ principles, along with electronic signatures and alarm management for environmental or process issues.
Its modular, scalable design allows for functional growth via specific apps (eBR, PAT, PQR, etc.) while ensuring compliance with GMP, FDA 21 CFR Part 11, and industrial cybersecurity standards.
Eliminates data silos by connecting the production plant vertically with management and ERP/QMS/LIMS systems.
Offers a holistic, contextualized vision of the entire manufacturing cycle on a single screen.
Enables data-centric proactivity for real-time evidence-based decisions and provides operational flexibility to adapt to specific budgets and paces.
Maximizes operational efficiency and reduces downtime through live intelligence.
Accelerates batch release using Review-by-Exception, reducing times from weeks to hours.
Guarantees data integrity and reduces risks by eliminating human transcription errors.
Reduces manufacturing costs through early detection of defective batches and ensures quality excellence for safer, more affordable medications.
Direct PLC interface for AHUs acting as a BMS and EMS.
Monitors room conditions (Temp, Humidity, Pressure, Ren/h, particles) and integrates "Clean & Black" services (WFI, purified water, compressed air, etc.).
Centralizes alarm management and Audit Trails.
Centralizes environmental data within the manufacturing context, breaking down traditional BMS silos.
Provides high-frequency monitoring for root cause analysis and automatically logs deviations.
Offers a holistic view of the Digital Plant, moving from reactive to proactive management.
Guarantees GMP and ALCOA+ compliance and reduces batch loss risks through proactive alarms.
Improves operational efficiency by optimizing energy and resources.
Direct real-time connection to PLCs and packaging lines using protocol-agnostic architecture (OPC-UA, MQTT, Modbus).
Enables bidirectional interaction for closed-loop control and utilizes zenon technology for robust automation.
Automatically calculates OEE without manual intervention and provides a global real-time dashboard.
Supplies precise data for scientific root cause analysis and contextualizes machine data with batch records (eBR).
Increases operational efficiency by correcting inefficiencies instantly and improves asset management to reduce unscheduled downtime.
Ensures ALCOA+ data integrity and drives the transformation toward a Smart Factory.
In-line real-time monitoring of Critical Quality Attributes (CQA) like pH or Raman/NIR spectra without sampling.
Enables closed-loop control for automatic parameter adjustments and predicts quality via multivariate analysis.
Aligned with CPV 4.0 methodology.
Guarantees process robustness and minimizes variability.
Eliminates bottlenecks caused by traditional offline laboratory analysis and provides early detection of deviations.
Reduces costs from defective products and facilitates Real-Time Release (RTR), accelerating time-to-market.
Ensures 100% pharmaceutical excellence and patient safety.
Automatically aggregates data from production, LIMS, and QMS.
Features an advanced statistical engine for Cpk/Ppk calculations and trend analysis.
Includes intelligent digital templates for RCA and CAPA analysis and centralized historical data access.
Automates "Data Mining," turning weeks of manual work into real-time reports.
Ensures ALCOA+ data integrity and facilitates root cause investigations through contextualized data.
Enables effortless regulatory compliance for annual reports and drastically reduces administrative costs.
Improves long-term process robustness through data-driven CAPA analysis.