SOTAX q-doc® – Compliant Data Management Software

Berner Lab offers SOTAX q-doc®, a modular software suite designed to give pharmaceutical laboratories full control over their data – from collection and analysis to approval, evaluation, and reporting. The latest version, q-doc® 4n, was released in December 2025 and is the current version available going forward.

Built For Compliance And Efficiency

Regulatory compliance and operational efficiency are the two key drivers behind most data management projects in the pharmaceutical industry today. SOTAX q-doc® 4n addresses both, helping your organization comply with current FDA data integrity guidelines and 21 CFR Part 11 regulations on electronic record keeping – whether you are working on a single workstation or across multiple networked instruments. With enhanced integration capabilities, q-doc® 4n now connects seamlessly with your existing data management infrastructure, delivering structured, secure data ready for advanced analytics and paperless reporting.

One Framework – Total Control

With q-doc®, you can use the same method on different systems, consolidate data from multiple test runs into a single report, and eliminate redundant user and password management. From electronic signatures and human-readable audit trails to LDAP integration, batch comparison, and LIMS import/export – the q-doc® framework is designed for an efficient, fully compliant workflow.

Key Features

• 100% scalable 3-layer software architecture with central MS-SQL database
• Device-independent methods that work across different instrument types
• More than 35 drivers for dissolution and physical testing instruments
• Modular design with extensions for LDAP integration, LIMS export, data trending, and more
• Report, evaluate and sign data directly in q-doc® with electronic signatures
• Batch reporting and comparison across time intervals for full traceability
• Human-readable audit trail and product version control for complete compliance
• Seamless integration with MES platforms and existing data management systems

Want To Streamline Your Laboratory Data Management?

Contact Berner Lab and we will help you configure the right SOTAX q-doc® solution to fit your workflows and ensure full data integrity.

Questions? Contact our product managers for more information.