GLP and GCP requirements
At our Contract Research Organization (CRO), we adhere to the highest standards of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) to ensure the integrity and quality of our research and clinical trials.
Good Laboratory Practice (GLP): GLP regulations govern the processes and conditions under which non-clinical laboratory studies are conducted. These regulations ensure the reliability and integrity of data used to support product applications. Our CRO maintains rigorous GLP standards by implementing comprehensive quality assurance programs, conducting regular audits, and ensuring that all laboratory personnel are adequately trained and qualified1.
Good Clinical Practice (GCP): GCP guidelines are designed to protect the rights, safety, and well-being of clinical trial participants. These guidelines ensure that clinical trials are conducted ethically and that the data generated is credible and accurate. Our CRO follows GCP guidelines by obtaining informed consent from all participants, maintaining detailed and accurate records, and ensuring that all clinical trials are conducted in compliance with regulatory requirements2.
By adhering to GLP and GCP standards, we ensure that our research and clinical trials meet the highest quality and ethical standards, providing reliable and credible data to support regulatory submissions and product development.
Document Management System
Our organization utilizes the DHC Vision eDMS, a cloud-based document management and training system, to ensure the efficient and compliant handling of Standard Operating Procedures (SOPs) and employee training records. This system is designed to meet the stringent requirements of highly regulated industries, such as life sciences, and adheres to guidelines from regulatory bodies like the FDA, EMA, and GxP.
Document Management: The DHC Vision eDMS facilitates the creation, review, approval, and distribution of SOPs and other critical documents through a secure, digital process. It supports flexible document coding, electronic signatures compliant with 21 CFR Part 11, and status management. The system also includes workflows for document review and approval, ensuring traceability and compliance.
Document Control: DHC Vision ensures that documents are distributed to the appropriate target groups in real-time. Employees receive notifications via email about new or updated documents, along with their specific tasks. The system also manages document validity, extensions, reactivation, and archiving, providing a comprehensive overview through dashboards and reports.
Training Management: The system seamlessly integrates training management with document control. It allows for the planning, execution, and monitoring of training courses, ensuring that employees are adequately trained on relevant SOPs. Training success can be tracked and documented, with records available on demand. The system supports both internal and external training, including for consultants and external IT staff.
By leveraging DHC Vision, our organization ensures that all SOPs and training activities are managed efficiently, promoting compliance, security, and continuous improvement.
Laboratory Information Management System
At Swiss BioQuant we have established a system based on self-programmed workflows and commercially available systems.