from the Source
Capture and store data securely, contemporaneously, and in context. Ensure every value, model, and configuration is traceable, supporting ALCOA+ principles and regulatory expectations across both R&D and GMP manufacturing
From orchestration setup to calculated CQAs, every action, change, and data point is recorded. Detailed audit trails and customizable reporting make it easy to prepare for inspections or reviews
Compliance Gaps
Laying the Groundwork for GxP Success – Data Integrity from Lab Bench to Batch Release
In pharmaceutical and life science industries, data integrity is not optional, it is foundational. Whether in regulated manufacturing or early-stage research, ensuring that data is accurate, traceable, and secure is essential for product quality, patient safety, and regulatory trust.
While formal GxP oversight may not apply in every R&D setting, the principles of good data governance are increasingly recognized as best practice throughout the development lifecycle. Not only does this foster scientific rigor, but it also supports effective investigations, tech transfers, and future submissions by ensuring continuity and traceability back to discovery.
A Digital Wraparound for GxP Readiness
SciY facilitates GxP compliance across lab and plant environments by extending data integrity, traceability, and control to your existing instruments and systems. Designed with Quality by Design (QbD) principles in mind, synTQ offers flexible, vendor-agnostic connectivity to a wide range of instruments and data sources. Whether used to manage a single instrument with synTQ Focus, or to support broader integration and control with full synTQ, it ensures secure data capture, traceability, and GxP readiness, without disrupting your existing setup.
Simplifying Scale-Up from Lab to Plant
Transitioning a process from R&D to a pilot and full-scale manufacturing can be complex and time-consuming. It often requires new validation steps, data reformatting, and even instrument upgrades. synTQ enables methods and workflow transferability with data integrity continuity and with minimal hardware changes. This reduces not only cost but also time and effort on validation transfer and protocol re-use.
