Probiomics S.r.l. is committed to ensuring that all analytical and technical-scientific activities are carried out to high standards of quality, reliability and regulatory compliance.
The Quality Management System is developed in accordance with ISO 9001:2015 and is integrated with the principles of Good Clinical Laboratory Practice (GCLP) for activities carried out in support of clinical studies.
Management is committed to:
- ensuring the accuracy, reliability and scientific robustness of generated analytical results;
- ensuring full traceability of biological samples from receipt to disposal (chain of custody);
- guaranteeing data integrity in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Durable and Available);
- ensuring that instruments, methods and systems are qualified, maintained and fit for their intended use;
- ensuring that personnel are adequately trained, competent and aware of their responsibilities;
- preventing and managing deviations, non-conformities and risks that may impact the quality of results or regulatory compliance;
- ensuring the protection of data and confidential information;
- ensuring availability of documentation and evidence required for sponsor audits and/or regulatory inspections;
- promoting the continuous improvement of the Quality Management System.
Management ensures that this Quality Policy:
- is appropriate to the organisational context and the risks associated with the activities carried out;
- is communicated, understood and applied by all personnel; is subject to periodic review within the Management Review process.
Every member of the organisation is responsible for complying with applicable procedures and for contributing to maintaining the effectiveness of the Quality Management System.
