Data management addresses different aspects of data collection, analysis, approval & evaluation, and reporting. Ensuring regulatory compliance and potential efficiency gains are the two main drivers for most software and data management projects at Pharmaceutical companies today.
From single workstations to multiple networked instruments, SOTAX software solutions improve your data collection, analysis, approval, and reporting processes – while help your organization to comply with current FDA data integrity guidelines and 21 CFR part 11 regulations on electronic records keeping.
Take full control of your data and manage all your methods, results, and users with q-doc.
Use the same method on different systems, consolidate data from multiple test runs in a single report, and avoid redundant management of users and their passwords. From electronic signatures, audit trail, and advanced user management to LDAP integration, batch comparison, and LIMS import / export functions – the q-doc® framework is designed for implementation of an efficient, fully 21 CFR Part 11 compliant system.
q-doc® – Data Management Software
Single workstations and networked solutions with built-in data integrity.
- 100% scalable 3-layer software architecture with central MS-SQL database
- Powerful framework with device-independent methods that can be used for different instrument types
- Modules extend the basic functionalities with LDAP integration, LIMS export, data trending, and more
- More than 35 drivers for dissolution and physical testing instruments
- Report, check & evaluate data directly in q-doc and sign with electronic signatures
- Easily create complete batch reports and compare batches over time intervals
- Human readable audit trail and product version control for full traceability and compliance
- Fulfils all requirements for implementation of a 21 CFR part 11 compliant system
Do you have any questions about q-doc? Don´t hesitate to contact us.