Data Processing
UK: MHRA Guidance on GxP Data Integrity – A sequence of operations performed on data to extract, present or obtain information in a defined format. Examples might include: statistical analysis of individual patient data to present trends or conversion of a raw electronic signal to a chromatogram and subsequently a calculated numerical result (as per Section 6.9 of MHRA – Guidance on GxP data integrity, March 2018).
There should be adequate traceability of any user-defined parameters used within data processing activities to the raw data, including attribution to who performed the activity. Audit trails and retained records should allow reconstruction of all data processing activities regardless of whether the output of that processing is subsequently reported or otherwise used for regulatory or business purposes. If data processing has been repeated with progressive modification of processing parameters this should be visible to ensure that the processing parameters are not being manipulated to achieve a more desirable result (as per Section 6.9 of MHRA – Guidance on GxP data integrity, March 2018).