synTQ Focus

Purpose-Built GxP Enabler for Individual Instruments

Description

synTQ Focus is a streamlined version of synTQ for single instruments. It provides a compliance layer aligned with 21 CFR Part 11 and data integrity principles, but with a simplified orchestration model. synTQ Focus is ideal when the full flexibility and interconnectivity of the original synTQ is not required. synTQ Focus allows instruments originally developed for research environments to operate in regulated settings.

Configurable &
Vendor-Neutral

Provides a data integrity software layer, enabling instrumentation to work in GxP environments

Streamlined Validation & Insights

Simplifies GxP validation and enables real-time analytics for faster, smarter decision-making

GxP without Reengineering

Enable compliance without modifying firmware or acquisition software; preserve your instrument’s core design

Built-In Digital Compliance

Provides audit trails and ensures data attribution, protection and contemporaneity according to ALCOA+, data integrity and 21CFR part 11 principles

Features

Fixed Orchestration Model

synTQ Focus interfaces with a single instrument, making it ideal for OEM bundling or deployment alongside specific instruments.

Agnostic Instrument Integration

synTQ Focus integrates with a wide range of instruments via standard protocols (OPC, Modbus, RS232, TCP/IP), making it adaptable across diverse hardware ecosystems.

21 CFR Part 11-Ready Architecture

synTQ Focus supports electronic signatures, audit trails, and secure data handling in alignment with regulatory expectations.

Qualification package available (IQ, OQ, CSV)

Qualification package -including Instrument and Operation Qualification, and Computer System Validation - can be ordered with synTQ Focus-driven systems.

Benefits

GxP Enablement without Reengineering: synTQ Focus adds a compliance layer to existing instruments without requiring firmware or software changes, facilitating 21 CFR Part 11 and ALCOA+ standards
Simplified Validation and Deployment: It reduces time and cost for end users by streamlining GxP validation and enabling straightforward parameters configuration – no coding required
Real-Time Analytics and Quality Control: Support for multivariate analysis tools enables real-time monitoring of CPPs and CQAs, enabling faster, data-driven decisions in regulated workflows

Digital Ecosystem Integration: It connects with the SciY Data Platform, supporting AI readiness and broader digital transformation strategies
Market Differentiation for Vendors: By embedding synTQ Focus, instrumentation and robotics vendors can offer compliance-ready solutions that open access to regulated markets and strengthen their competitive edge

Related Solutions

Enabling GxP (GLP, GMP)

Unlocking GxP Readiness in Everyday Instrumentation and Robotics

Enabling GxP Compliance for Non-GxP Instrumentation

How synTQ Focus Supports Regulatory Readiness through Data Integrity and Digital Enablement

Interested in synTQ Focus for Your Instrument?

If you're an OEM product manager looking to enable GxP compliance and orchestration on your instrument, synTQ Focus offers a streamlined, configurable solution that adds a robust compliance layer without reengineering your hardware.

We’re already collaborating with partners to deliver tailored versions of synTQ Focus that integrate seamlessly with their systems, ensuring optimal performance and regulatory alignment.

Want to explore how synTQ Focus can work for you? We’d love to hear from you. Reach out to start the conversation and discover how we can support your digitalization journey.