Produced in Partnership with ERWEKAReviewed by Emily MageeMay 21 2026
For many years, pharmaceutical labs performing dissolving testing assumed that full compliance with 21 CFR Part 11 required the use of an external PC. The DT 950 Series from ERWEKA challenges that view, demonstrating that true compliance may now be achieved within a fully self-contained system.
This technical advancement represents a more practical and efficient way of working while meeting strict regulatory requirements for data integrity and traceability.
Image Credit: Stefan Holm/Shutterstock.com
Rethinking the “Compliance Myth”
The idea that independent systems cannot meet 21 CFR Part 11 requirements stems from the limitations of previous systems.1 Historically, dissolution testers lacked the processing capability or built-in controls required to maintain electronic documents, user access, and audit trails. As a result, labs depended on external PCs and other software to bridge the gaps.
The regulation, however, does not require an external computer. 21 CFR Part 11 addresses data management by prioritizing security, traceability, and responsibility over system design. As stated in industry recommendations, compliance is determined by how data is created, maintained, and safeguarded.
With modern embedded technology, these requirements can now be met directly within the device. The DT 950 Series was created with this in mind, eliminating the need for external systems while maintaining regulatory compliance.
Image Credit: Erweka
Embedded PC Technology: Compliance Built In
The DT 950 is powered by embedded PC technology that is fully integrated into the instrument.2 All important functions are operated via a seven-inch touchscreen interface, allowing users to control both testing and compliance aspects from one location.
This architecture has several clear benefits:
- Fewer components to maintain and validate
- Reduced risk of system failures due to software or connectivity difficulties
- Simplified validation process
By integrating everything into a single system, ERWEKA eliminates the need to manage separate hardware and software environments. This simplifies day-to-day operations and decreases the possibility of system issues.
Integrated Audit Trail: Full Traceability
21 CFR Part 11 requires the use of secure, time-stamped audit trails.3 These must document all important operations, such as method configuration, updates, and test execution.
The DT 950 Series offers a fully integrated audit trail that records every action taken within the system, with no need for additional software or databases. This ensures:
- Full traceability of all actions
- Established user accountability
- Protection from unnoticed data modifications
When everything is recorded in the same system, there is a lower risk of missing or conflicting data, making inspections and audits considerably simpler.
Guided Compliance with TestAssist
Another notable aspect of the DT 950 Series is ERWEKA's TestAssist. Setting up dissolution procedures can occasionally pose compliance issues, particularly when parameters deviate from pharmacopeial guidelines.1
TestAssist aims to mitigate this risk by walking users through the setup process step by step. It also runs real-time checks to ensure that only compliant parameters are used, as defined by USP, EP, and JP standards.
This means that compliance is integrated into the workflow rather than checked afterward, preventing errors before they occur and promoting more consistent outcomes across users and laboratories.
Secure Data Management and Connectivity
Data security is another important aspect of 21 CFR Part 11. Systems must preserve electronic records while also allowing them to be accessed and transferred as needed.
DT 950 addresses this via:
- Role-based user management that manages access
- Protected internal data storage
- Controlled export options, such as FTP transfer or LIMS integration
This allows labs to maintain high data privacy while also linking to larger networks as needed. It also lowers the need for manual data processing, which might lead to errors or risks.2
Simplifying Workflows Without Compromising Compliance
Traditional setups that rely on external PCs can introduce additional layers of complexity, including managing multiple systems, additional training, and ongoing IT support.
DT 950 simplifies workflows by putting everything into a single instrument. Labs can benefit from:
- Faster setup and testing
- Simplified training for new users
- Reduced maintenance and validation efforts
At the same time, compliance is not decreased. Rather, in many cases, it is strengthened by the system's ability to enforce best practices automatically.
Modernizing Dissolution Testing Workflows
As expectations around data integrity continue to grow, pharmaceutical labs are under pressure to implement dependable and efficient solutions. The transition to freestanding, digitally integrated instruments is part of a larger industry trend.
The DT 950 Series is a good example of this direction, demonstrating that stringent regulatory standards can be achieved without sophisticated system designs. In doing so, it provides a more practical and current method for dissolution testing.
The idea that standalone dissolution testers cannot meet 21 CFR Part 11 standards has been proven untrue.6 Advances in embedded technology have enabled full compliance within a single, integrated system.
The ERWEKA DT 950 Series combines embedded computers, an integrated audit trail, guided compliance solutions, and secure data management. As a result, the system not only meets regulatory requirements but also simplifies day-to-day operations.2
For laboratories aiming to reduce system complexity, streamline validation, and strengthen data integrity, ERWEKA’s standalone compliance approach offers a clear path forward.
References and Further Reading
- US FDA (2022). Data Integrity and Compliance With Drug CGMP: Questions and Answers. U.S. Food and Drug Administration. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
- Erweka. Digital Dissolution Tester, DT 950 Series. Erweka. Available at: https://www.erweka.com/products/dissolution-testers/usp-1-2-5-6-single-devices/dt-950/.
- Ingilizovska, B. (2026) FDA 21 CFR Part 11 Audit Trails: Definition, requirements, and compliance. SimplerQMS. Available at: https://simplerqms.com/21-cfr-part-11-audit-trail/.
- Distek, Inc. (2021). Clarifying and meeting the requirements of 21 CFR Part 11 and Data Integrity for dissolution testing, PHARMACEUTICAL WHITE PAPER. No. 216. Distek. Available at: https://www.distekinc.com/media/white-papers/requirements-for-21-cfr-part-11-and-data-integrity-for-dissolution-testing-wp_216.pdf.
About ERWEKA
ERWEKA is an international manufacturer of test equipment for the pharmaceutical industry. In addition to large pharmaceutical and life science companies, we supply development and contract laboratories as well as universities around the world with equipment for the development and testing of medicines.
ERWEKA was founded in Germany in 1951 and has been an integral part of the Verder Scientific Division since 2023. As a manufacturer with extensive experience in the testing equipment industry, ERWEKA offers the full range of tablet testing devices for solid dosage forms. Our benchmark is top quality. From development, design, and production to service for our devices, we are uncompromising in our commitment to premium quality. ERWEKA stands for excellent product quality, attractive design and individual customer care. Our customers have been relying on this for over 70 years.
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