- We know the legal requirements for conducting clinical studies and developing medical devices and know how to ensure these requirements with the help of a quality management system (QMS).
- We have many years of experience in the standardization of processes (Standard Operating Procedures, SOPs) and correct documentation. We provide templates for common processes in a clinical study.
- We operate the web application "orca" as an easy-to-use QMS solution and guide researchers to set it up and manage it as a digital QMS. Thus, the necessary documents and evidence are available for inspection at any time. The clearly defined processes and responsibilities help to avoid unnecessary misunderstandings in everyday clinical trial work.
- We know how audits and inspections are conducted and can prepare and support them accordingly so that research projects are not jeopardized by missing or faulty processes and documentation.
We provide comprehensive and personal advice on the following questions:
- What is a quality management system (QMS) and why is it relevantfor my study?
- What are the legal requirements for clinical studies?
- What are the legal requirements for the development of medical devices?
- What are the objectives of a QMS in clinical research?
- What are Standard Operating Procedures (SOPs)?
- How do I set up and maintain a QMS?
Support in setting up a QMS
We conduct a requirements analysis for your study, identify the critical work processes, and prepare a risk assessment that highlights any gaps in the QMS and offers suggestions for improvement. We assist in the creation and management of Standard Operating Procedures (SOPs). For this purpose we rely on a library of standardised SOPs, which only need to be adapted to the needs of the research group. The QMS solution "orca" is the ideal tool for this.
Procedure for the setup of the QMS:
- Identification of the critical work processes
- Identification of interfaces to partners and service providers
- Create SOPs for critical processes (templates available in "orca")
- Train responsible persons
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:
- Preparation of an audit plan
- Performing internal audits
- Suggesting improvements (audit report)
- Support with the implementation of the improvement suggestions
Support during audits & inspections
Inspections - especially by the Swiss drug authority Swissmedic - are becoming increasingly frequent. They are a common quality control instrument and focus primarily on patient safety.
We can advise you throughout the entire process of an inspection by Swissmedic or an audit by the Ethics Committee. Good preparation and guidance by experienced DKF staff who know and understand both sides can facilitate the inspection/audit process and thus minimize the number and severity of inspection and audit findings. We will prepare you for the inspection visit in a training session and support your study team during the official appointment.
Addressing inspection finings (CAPA)
When preparing an inspection report, we support you by creating and implementing the Corrective And Preventive Action (CAPA) plan. This is an action plan that must be submitted to and accepted by the appropriate authority. Together with you, we work out a proposal that shows which measures can be taken to address the inspection findings. Further, we support study teams in the implementation of these measures.
Validation of computer systems and use of medical devices
Infrastructure and equipment used in clinical trials must function correctly, comply with legal requirements and ensure data protection. Therefore, computer systems for data acquisition, for example, must be documented, tested and operated in a controlled manner. This procedure is called computer system validation. Medical devices used in clinical studies must also be tested and documented if they are relevant to the study results.
We advise you on the use of computer systems, help you to document the systems and manage the inventory.