Implementation of cloud-based applications in regulated bioanalytical laboratories - a recommendation from the...

The adoption of cloud-based applications in regulated bioanalysis has progressed cautiously, largely due to uncertainty regarding the interpretation of existing regulatory expectations and the distribution of responsibilities between organizations and service providers. This recommendation paper from the European Bioanalysis Forum (EBF) provides a bioanalytical perspective on cloud implementation, emphasizing the importance of intended use, data criticality, and cross-functional collaboration throughout the data lifecycle. Rather than prescribing technical solutions, it outlines key considerations for third-party risk management, vendor oversight, and the consistent and proportionate application of existing regulatory principles. Cloud adoption does not change fundamental requirements for data integrity, system validation, or compliance, but introduces a more complex distribution of responsibilities that must be clearly understood and actively managed. The paper supports a risk-based, fit-for-purpose approach that enables confident and effective use of cloud technologies in regulated bioanalysis.