Laboratory software q-doc®

for the pharmaceutical industryproduction environmentanalysis

Product Overview
q-doc® is a data management software delivering single‑workstation and networked solutions with built‑in data integrity for laboratory and manufacturing environments. It supports reporting, evaluation and electronic signing of test data with full traceability and is designed for integration with instruments and enterprise systems.

Key Benefits

• 100% scalable 3‑layer software architecture with central MS‑SQL database
• Device‑independent framework enabling reusable methods across different instrument types
• Modular design to extend core functionality (LDAP integration, LIMS export, data trending, and more)
• Over 35 drivers for dissolution and physical testing instruments
• Direct reporting, verification and evaluation of results within q-doc® including electronic signatures
• Generate complete batch reports and compare batches over time
• Human‑readable audit trail and product version control for traceability and compliance
• Designed to support implementation of a 21 CFR part 11 compliant system

Highlights

• Integrate Instruments: Standard q-doc® drivers cover a wide range of instrument types from multiple vendors, control test parameters and automatically record results to ensure critical test data traceability.
• Integrate Processes: Process drivers guide operators through manual tests with step‑by‑step instructions; all user actions and metadata (date, time, serial numbers) are automatically logged and reported.
• Integrate with your Ecosystem: DataLink™ interfaces enable bi‑directional data exchange with LIMS / MES / ERP systems and third‑party packages (examples include PAS‑X and Waters Empower® CDS).
• Empower your AI: q-doc® structures and digitalizes documentation workflows to accelerate processes, reduce manual effort and provide clean, structured data suitable for DOE and predictive analytics.
• Built‑in Data Integrity: Automatic electronic audit trails record who did what, when and where; product records include methods, tolerance limits, pass/fail criteria and device settings.
• Operational Excellence in Dissolution: Maximize instrument utilization, route test runs to any dissolution tester, analyze spectra online and link HPLC results to dissolution data for consolidated reporting.
• In‑Process Control (IPC): Support rapid IPC decisions from raw material testing to final dosage form physical property testing.
• Managing Large Networks: Support for workgroups, virtualization, mobile access and instrument pooling simplifies operation across departments and sites.
• Future‑Proof Installation: Software support contracts include priority service and update licenses to keep installations current.

Technical specifications

• Architecture: 3‑layer, fully scalable
• Database: central MS‑SQL database
• Drivers: more than 35 drivers for dissolution and physical testing; integrates over 40 instrument types
• Modules: LDAP integration, LIMS export, data trending and expandable modules
• Compliance: designed to fulfill requirements of 21 CFR part 11 (electronic signatures, audit trail, version control)
• Data exchange: DataLink™ interfaces for LIMS / MES / ERP integration (supports common systems such as PAS‑X and Empower® CDS)
• Traceability: human‑readable audit trail, product version control, automatic logging of metadata
• Process control: process drivers with operator guidance and automatic protocoling of user actions
• AI readiness: structured data outputs suitable for DOE and predictive analytics
• Network features: instrument pooling, virtualization, mobile tablet access, centralized reporting from any PC
• Reporting: batch reporting, data comparison over time intervals, online spectral analysis integration
• Support: software support contracts with update licensing