Automation and Control of Machines and Production Equipment
Y-Pharma implements advanced automation and control systems that record and monitor operations in real time, increasing the performance of operating equipment and ensuring traceability and efficiency in production. SCADA.
Critical Services Control
Automated management of essential services such as purified water generation, sanitizing steam boilers and autoclaves, and cooling service systems, refrigeration mixing and steam or electric heating, with digital historical records and continuous control to ensure compliance with quality standards.
Monitoring Clean Areas
Control of critical variables such as temperature, humidity, differential pressure, integrity control of HEPA filters and air flow in clean areas, with constant digital monitoring, guaranteeing an optimal environment for pharmaceutical production.
Production planning and management with AI
Y-Pharma integrates artificial intelligence to optimize production planning, improving efficiency and reducing waste.
Warehouse Management System (WMS)
The platform digitizes and automates inventory control and warehouse management, optimizing the FIFO flow and rotation of materials and finished products throughout the production chain.
Predictive and Corrective Maintenance
Implementation of statistical and probabilistic generative artificial intelligence systems that predict failures in critical equipment and optimize the preventive maintenance plan, minimizing downtime, unforeseen stops during operation and increasing the useful life of assets.
Comprehensive Process Traceability
Y-Pharma guarantees complete traceability at every stage of production, from the input of raw materials to the output of finished products, ensuring total control of the operational line and the quality control stages of the process and product.
Release of Lots
Automated management of finished product releases through a system that centralizes all quality and production records, ensuring data integrity and complying with strict regulations.
Digitalized LAYER
Integrated digital management of corrective and preventive actions (CAPA) with artificial intelligence, allowing a rapid and precise response to process deviations using predictive models and simulations to anticipate and correct them before they affect production quality.
Document Management
Secure digital warehouse for specifications, analysis methods, analysis and stability certificates, R&D tests, SOPs, Batch Record production order records, OOS deviations, change control, DMFs, audits facilitating accessibility and guaranteeing the integrity of critical documents complying with CFR21 part 11 .
Quality Risk Analysis
Y-Pharma includestools for risk analysis (FMEA, HACCP) integrated with artificial intelligence and augmented reality, allowing an accurate and preventive assessment of risks throughout the production chain.
LIMS System for Laboratories
Digital laboratory data management (LIMS), optimizing quality control in each analysis and reducing human errors.
Accident and Incident Management
Centralized platform to record, analyze and manage legal requirements, facilitating the certification of ISO 45000 and ISO 14000 standards
Digital Training and Records
Interactive training modules ensure all staff are up to date and trained in procedures, methods and training. Includes digital signatures and ensures data integrity to comply with safety and quality regulations.
