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SOFT Instrument Link was created to improve the data integrity in regulated laboratories. In these environments, instruments are frequently integrated with LIMS and ELN systems. If practices such as GLP (Good Laboratory Practices) or GMP (Good Manufacturing Processes) are employed, data integrity is of utmost importance and frequently inspected and enforced by regulatory oversight bodies.
The European Bioanalysis Forum (EBF) hosted a number of workshops around this topic at its conferences. At EBF, users and vendors came together to discuss this issue and brainstorm solutions.
Following the second e-environment focused workshop at the 12th EBF Open Symposium in November 2019, several community members authored a paper titled Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC–MS from the European Bioanalysis Forum. This has been published in the Bioanalysis journal in 2020.
The paper highlighted a gap between the health authorities’ data integrity expectations and the availability of software that meets these expectations in securely transferring data between a LIMS systems and LC-MS instruments.
To mitigate DI risks and negate the need for manual and time-consuming quality-control steps a vendor neutral, secure, file-based interface solution has been proposed and presented at the 13th EBF Open Symposium in November 2020.
The team discussed the approach more broadly, leading to a fruitful collaborartion with the American Association of Pharmaceutical Scientists (AAPS).
The approach is based on the open standard AnIML data format, secured via widely used digital signatures with a near zero impact on user workflows. This solution is designed to address data integrity gaps and to avoid further forced measures and process modifications due to inspection findings.
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