synTQ

synTQ (synchronised Total Quality) is an award-winning knowledge management and quality-centric control software suite developed by SciY, designed to orchestrate and synchronise real-time process control across manufacturing workflows. It unifies real-time data collection, advanced analytics, and process control within a single scalable platform, enabling manufacturers to accelerate product development, optimise efficiency, and ensure regulatory compliance. Trusted by approximately 65% of leading pharmaceutical companies and with more than 200 installations globally, synTQ is also deployed across the food, chemical, and consumer goods industries.

By leveraging Process Analytical Technology (PAT) and Quality by Design (QbD) principles, synTQ delivers measurable outcomes: one leading biopharmaceutical company tripled their titer in a batch process, while another top pharmaceutical company reduced a 30-day batch manufacturing process to a 90-minute continuous manufacturing workflow using synTQ.

Core Capabilities

• Real-time and offline data collection, analysis, and quality assurance across development and production stages
• Multivariate and univariate data recording, management, and knowledge generation
• Multivariate Statistical Process Control (MSPC) for intelligent process optimisation
• Quality predictions enabling plant operators and automation systems to drive continuous improvement
• Method lifecycle management with support for simulation and digital twin functions
• Correlation and contextualisation of online, offline, at-line, and in-line measurement approaches within a single data management system

Vendor-Agnostic Connectivity and Integration

• Instrument vendor-agnostic platform capable of connecting with any device that has a communications interface and a known protocol
• Connects instrumentation, multivariate analysis (MVA) packages, automation systems, and third-party systems including MES, historian, and LIMS from any vendor
• Standard, modular, and universal hardware and software integration with new adapter modules added frequently
• Integration with SciY's broader digitalisation platform for connected data, methods, and systems across the product lifecycle
• Supports a complete Process Analytical Technology implementation from a single unified environment

Scalability Across Stages and Environments

• Supports lab automation, batch processes, continuous manufacturing, and process-on-demand
• Tailored editions available for every stage, from early investigative projects with single unit operations to plant-wide distributed systems running multiple unit operations globally
• Enables seamless scale-up and scale-out using validated methodologies, transitioning from pilot plant to enterprise-wide GMP manufacturing
• Advanced control strategies applicable from laboratory and small-scale manufacture through to full-scale GMP production
• Modular architecture allows new capabilities to be added as requirements grow and evolve

Regulatory Compliance and Data Integrity

• Compliant with 21 CFR Part 11 and data integrity principles
• Enables instrumentation to operate under GLP and GMP environments
• ISO 9001 and ISO 27001 accredited
• GxP-ready, supporting validation and compliance requirements for Quality by Design manufacturing processes

Key Business Benefits

• Improved product quality and consistency through enhanced quality assurance
• Reduced in-process testing and accelerated manufacturing via real-time product quality measurements
• Lower operational costs by reducing waste, giveaway, and rework while producing more from existing facilities
• Elimination of unconnected islands of digitalisation through a single, unified platform
• Faster, more reliable, and more repeatable manufacture of high-quality products

synTQ is deployed as a scalable, enterprise-grade platform with editions suited to organisations at every stage of maturity. It integrates with SciY's digitalisation ecosystem and supports connections to a wide array of third-party systems, making it a flexible foundation for both current operational needs and future growth in regulated manufacturing environments.