Study and Quality Management

The Study and Quality Management Unit is part of the RIBOLUTION Biomarker Center at Fraunhofer IZI and works closely with the RNA Biomarker Unit, the Next Generation Diagnostics Unit and the Bioinformatics Unit. The Unit’s activities focus on the quality assurance of the design and development of medical devices and in vitro diagnostics (IVDs) in particular, for which the following regulations serve as important basis: the European Directive 98/79/EC on in vitro diagnostic medical devices, the German Act on Medical Devices (MPG) and the harmonized standard DIN EN ISO 13485 as well as additional associated standards.

 

Offers Quality Management

  • Assistance for the implementation of a quality management system according to DIN EN ISO 13485 or DIN EN ISO 9001
  • Provision of quality-compliant document templates; e.g. general quality management SOPs, experimental work instructions, customer-specific instructions for use of equipment, documents for equipment qualification, specific design and development documents
  • Drafting of quality-compliant documents according to customer needs
  • Review and optimization of customer documents

Offers Data Management

  • Design and development of custom-specific data management systems

The implementation of a quality management system according to DIN EN ISO 13485 or DIN EN ISO 9001 provides a mechanism for constant maintenance and improvement of the high quality standard of the RIBOLUTION Biomarker Center. The overall aim is to ensure standardized (laboratory) processes for a quality-compliant design and development of in vitro diagnostics (IVDs). The Unit’s key competences are:

  • Authoring of SOPs and work instructions
  • Implementation of quality-compliant documentation requirements to ensure complete traceability of the design and development process; incl. controlled records, development protocols, meeting notes etc.
  • Effective training processes to secure and improve employee’s high level qualifications; incl. SOP training courses, in-depth on-the-job training, equipment instructions, regular quality management training courses as well as external advanced trainings
  • Quality assurance of the procurement of raw materials to secure a consistent quality of materials and reagents; e.g. authoring of specifications, supplier assessment, quality control procedures for delivered raw materials, quality-compliant labelling and storage, inventory control system
  • Registration and qualification of laboratory equipment incl. authoring of internal instructions for use, establishment and regular performance of functionality tests for a continuous monitoring of the qualification status
  • Documented procedures for the design and development of IVDs such as market and product requirement specifications (MRS, PRS) as well as development plans and protocols
  • Deviation management incl. definition of corrective and preventive actions (CAPA)
  • Change Control
  • Risk management process according to DIN EN ISO 14971
  • Securing traceability of all samples and every process a sample has passed through by using barcoded documents and materials as well as barcode sample tubes
  • Analytical and clinical validation
  • Determination and documentation of the organizational structure; e.g. authoring of job descriptions, definition of responsibilities, description of the organigram, authoring of the quality management manual, compiling of the management review
  • Internal audits in terms of a continuous improvement process

A thorough study design is the most important phase of both the early biomarker discovery and the final validation. Sample cohorts are always carefully planned and selected in consultation with clinical Key Opinion Leaders (KOLs). All screening studies are explicitly driven by the actual clinical situation and the users’ needs. The contribution of KOLs during the period of test development allows for a direct evaluation of the IVD’s usability and an early contact for future addressees of the respective IVD.

Key competencies:

  • KOL network for uroglogic oncology
  • Study design and statistical analysis are performed in cooperation with the Bioinformatics Unit at the RIBOLUTION Biomarker Center

Besides paper-based documentation, a data management system (DMS) that has been specifically designed and developed for the requirements of the RIBOLUTION Biomarker Center is used to record all laboratory sample processing steps. The DMS provides a detailed history and complete information for every sample and about every process a sample has passed through. It lists all clinical sample data and specifies for each process step the respective date and the performing person, the current location of a sample as well as all quality data measured. Thus, a complete monitoring of all samples and analysis steps is ensured at any time.

Key competencies:

  • Design and development of custom-specific data management systems
  • Adaption and precise modulation of workflows according to specific laboratory requirements and/or customer requests
  • Very user-friendly graphical user interface (GUI)
  • Graphic visualization of data and process information
  • Export of analyzed data in various formats such as Excel tables (e.g. for iterative study management) or JSON data streams (e.g. for downstream bioinformatics analysis)
  • Availability of detailed operating instructions allow a simple usage by laboratory staff

Ribolution

The Study and Quality Management Unit is part of the research association "RIBOLUTION – integrated platform for the identification and validation of innovative RNA-based biomarkers for personalized medicine", which is supported by the Fraunhofer-Zukunftsstiftung (Fraunhofer Future Foundation).

New RNA biomarkers for complex disorders (e.g. oncological, chronic-inflammatory and degenerative disorders) are being identified in the RIBOLUTION project by genome-wide screening processes. RIBOLUTION also includes so-called non-coding RNAs whose significance as potential biological markers have only been investigated in the recent past.

Subsequent to the screening phase, potential biomarkers are evaluated with regard to their diagnostic and prognostic significance. Biomarkers with the ability to indicate a disorder or its course or forecast the response to therapies are of special interest.