SOTAX Releases q-doc® Version 4n, Advancing Digitalization and Automation in Pharmaceutical Quality Control

New release introduces DataLink™ for Waters Empower®, DataLink™ for Körber PAS-X MES, standardized system connectivity, and enhanced dissolution workflows

June 2026 - SOTAX announced the release of q-doc® Version 4n, the latest version of its modular software suite for seamless, traceable, and compliant laboratory data management. The new release strengthens q-doc® connectivity with standardized DataLink™ import/export functionalities, including integrations with Waters Empower® CDS, Körber PAS-X MES, and LIMS/MES/ERP systems.

The release supports SOTAX’s broader objective to help pharmaceutical manufacturers advance digitalization, automation, and continuous assurance across critical quality workflows. As outlined in the SOTAX perspective paper Global Pharmaceutical Digitalization, the industry is shifting from retrospective quality-by-inspection toward data-centric, continuously assured manufacturing models supported by interoperable data, governed computerized systems, and inspection-ready decision records.

A key highlight of q-doc® Version 4n is DataLink™ for Waters Empower®, which enables q-doc® to automatically create high-performance liquid chromatography (HPLC) sample sets in Waters Empower® CDS for dissolution workflows. By linking dissolution data with analytical LC results, laboratories can reduce manual handoffs, improve data consistency, and strengthen traceability from testing through evaluation.

q-doc® Version 4n also includes DataLink™ for Körber PAS-X MES, a certified interface that connects in-process control test data with manufacturing execution systems. This functionality helps create a digital bridge between IPC laboratories and production environments.

The new release also expands standardized connectivity through DataLink™ for SQL Import, Job Import, SQL Export, and LIMS Export, supporting automated batch and test run registration, file-based data exchange, paperless batch record export, and automated output as PDF or Microsoft Excel®-compatible files.

For dissolution testing, q-doc® Version 4n introduces new features for Xtend™ systems, including staging for immediate-release products, staging for extended and delayed-release products, and f1 and f2 dissolution profile comparison with seamless access to archived tests. The release also supports built-in UV-Vis qualification workflows directly from q-doc®, helping laboratories standardize qualification routines from an installed and validated software platform.

Together with platforms such as Xtend™ for fully automated dissolution, JetX™ for automated assay and content-uniformity sample preparation, AT50 for automated online and at-line physical testing, and q-doc® for integrated data management, SOTAX provides a focused instrumentation and data layer that supports repeatable measurements, standardized workflows, and governed data across laboratory and manufacturing environments.

With q-doc® Version 4n, SOTAX continues to advance its vision of “Data without Borders” by helping laboratories integrate instruments, processes, and existing IT ecosystems for more efficient, paperless, and compliant data management.

About Sotax

About Sotax The SOTAX Group is the leading global provider of complete testing solutions for Research and Development (R&D), Quality Control (QC), and In-Process Control (IPC) departments of the pharmaceutical industry. SOTAX’s instruments, software, and services are recognized by their customers worldwide as the industry benchmark for best-in-class solutions. It is also the only pharmaceutical services supplier specialized in R&D for dissolution and release testing. The company is offering a high level of expertise for complex dosage forms testing as well as an FDA-inspected facility for routine cGMP testing. Its laboratories, located all over the globe, operate for clients worldwide ranging from virtual companies to big Pharma including generic.