Validation, data integrity and quality assurance of GCP-relevant computerized systems

We provide consulting in the field of clinical research and development, both in process optimization and in the development of quality management systems. In addition, we support CROs, service providers and software developers in meeting the high demands on the validity of processes and data as well as the suitability of the software tools used.
…read more

Efficiency and cost control through process orientation and risk-based technology deployment

In the field of clinical drug research, the requirements for computerized systems and processes that support the setup, execution and subsequent evaluation of clinical trials are particularly high. On the one hand, patient safety is a priority during ongoing studies; on the other hand, the data integrity of the acquired data needs to be guaranteed. Both aspects (patient safety and data integrity) can be achieved through process-oriented quality management.

In particular, the development and application of technologies such as

  • eCRF and EDC
  • eSource technologies (e.g. electronic Patient Reported Outcomes – ePRO),
  • IVRS / IWRS and
  • eClinical platforms

represents a particular challenge. Heterogeneous system landscapes with many different (often non-standardized) interfaces and many users worldwide pose a high risk to the data integrity of the collected and processed data.

By applying the GAMP 5® principles to the processes and system landscapes in this field, a targeted validation of such systems can be realized. The application of this process-oriented, risk-based approach for the validation of GCP processes and the qualification of the IT systems that support these processes allows a resource-friendly quality management for these already very costly projects. Even highly complex eClinical Platforms can be efficiently qualified using end-to-end validation.

Our service in the area of Good Clinical Practice (GCP)

  • Consulting for quality assurance of GCP data and systems
  • Development and optimization of quality management systems (QMS)
  • Trainings and Workshops
  • Support in quality and change management
  • Efficient validation strategies
  • Support of sponsors and suppliers (e.g. CROs, laboratories)
  • Support in tool selection and supplier evaluation
  • Auditing of software suppliers (on-site)
  • Migration planning and concepts
  • Process analysis and optimization when using computerized GCP systems
  • Performing data flow and data integrity analyses
  • Operational support in the implementation of validation activities
  • Testing of GCP-compliant archiving systems and document management systems