QC of e data
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Is there an expectation for checkers to check (QC) the e data on systems? Currently our process is for QC of the paper study package and we have defined our regulatory data as hybrid i.e. it is both paper raw (data package) and electronic raw (system data) that is archived. We are still printing all data out until we move all process to electronic format. QA do audit the e data but our QC process is still paper based.
RQA GLP Committee
This is not an ideal situation, but it would be useful to review the findings that QA have to see if things are being focused in the right areas when QC checking. If they are not finding anything in the e data check that you couldn’t find by reviewing the paper data then your procedures are probably sufficient. However, it does raise the question as to why you QC some data and not others before it reaches QA.
Conduct a risk assessment and consider the impact of errors that could be missed by not doing a full QC check.
Potentially it might be quicker to check the data on-line rather than printing it, and really the e-date should also be QC checked, but the level of this will depend on the level of validation, whether all meta-data is being reviewed, and whether or not you look at the audit trails.