UK: MHRA Guidance of GxP Data Integrity – Raw data is defined as the original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state (synonymous with ‘source data’) (as per Section 6.2 of MHRA – Guidance on GxP data integrity, March 2018)
Raw data must permit full reconstruction of the activities. Where this has been captured in a dynamic state and generated electronically, paper copies cannot be considered as ‘raw data’ (as per Section 6.2 of MHRA – Guidance on GxP data integrity, March 2018)
In the case of basic electronic equipment that does not store electronic data, or provides only a printed data output (e.g. balances or pH meters), then the printout constitutes the raw data. Where the basic electronic equipment does store electronic data permanently and only holds a certain volume before overwriting; this data should be periodically reviewed and where necessary reconciled against paper records and extracted as electronic data where this is supported by the equipment itself.
In all definitions, the term ‘data’ includes raw data (as per Section 6.2 of MHRA – Guidance on GxP data integrity, March 2018)