Consulting

We provide comprehensive and personal advice on all questions regarding your individual Quality Management System (QMS). We check which Standard Operating Procedures (SOPs) and further documents you need and how to best implement them.

Support in setting up a QMS

We work with you to establish a GCP-compliant QMS; in particular, we support you in

• setting up a suitable organisational structure, drafting job descriptions and allocating training within the portfolio.
• creating and managing SOPs and working instructions based on templates and taking into account the specific characteristics of your research group and your study.
   

To help you set up the QMS, the DKF offers the web-based, electronic solution Orca – customised for quality management in academic clinical research.

Auditing and improving existing QMS

Through an analysis of the existing QMS, we identify weaknesses and suggest improvements. This way, we ensure that the QMS meets the legal requirements and the expectations of auditors.

Procedure for maintaining the QMS:

1. Preparation of an audit plan
2. Performing internal audits
3. Suggesting improvements (audit report)
4. Support with the implementation of the improvement suggestions

Support during audits & inspections

We advise you throughout the entire process of an inspection by Swissmedic or an audit by the Ethics Committee. Thorough preparation and support from experienced DKF staff, who are familiar with and understand both sides, can facilitate the inspection or audit process and thus minimise the number and severity of any findings. To this end, we prepare you for the inspection or audit through a training session and support your study team during the official visit.

Addressing inspection finings (CAPA)

We support you in creating and implementing the Corrective And Preventive Action (CAPA) plan. This plan lists the measures that can be taken to address the inspection findings. It must be submitted to and accepted by the appropriate authority. Furthermore, we support your study team in the implementation of the proposed measures.

Validation of computer systems

Computer systems used in clinical trials must function correctly and comply with legal requirements. Not least, data protection must be guaranteed. These factors are verified and documented as part of computer system validation (CSV).

The data management systems provided by the DKF (REDCap® and secuTrial®), as well as the statistical software R and the DKF eQMS solution Orca, are validated by the DKF, and the relevant documentation can be made available during audits and inspections. Should your research group use any other GCP-relevant software, we would be happy to assist you in developing an appropriate validation plan and carrying out the validation.

Classification of «Software-as-Medical Device (SaMD)»

Many research projects develop software solutions that are both interesting and useful for medical staff and patients, but which, under the MDR (EU), are classified as medical devices (more specifically: «Software-as-Medical Device») and, in the interests of patient and data safety, may not be used in everyday clinical practice without prior qualification and registration with Swissmedic. We can advise you on whether your software solution is to be classified as a medical device and support you with the qualification and Swissmedic registration for «in-house use» at the USB.

Swissmedic answers the most important questions on this topic on its ‘Frequently Asked Questions on Medical Devices’ page. Of particular relevance to «Software-as-Medical Devices» are the references to «medical device software» under «Regulations for specific medical devices».