Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC-MS from the...

In this paper, the European Bioanalysis Forum reports back from the discussions with software developers, involved in regulated bioanalysis software solutions, on agreeing to data transfer specification in the bioanalytical labs' LC-MS workflows as part of today's Data Integrity (DI) challenges. The proposed specifications aim at identifying what consists of a minimum dataset, that is, which are the pre-identified fields to be included in DI proof bidirectional data transfer between LC-MS and information management systems. The proposal is an attempt from the European Bioanalysis Forum to facilitate new software solutions becoming available to increase compliance related to DI in today's LC-MS workflows. The proposal may also serve as a template and inspiration for new data transfer solutions in other workflows.