Thursday 7 April 2016

Good Documentation Practice

Siegfried Schmitt has written an interesting article for BioPharm International, titled “Good Documentation Practice: Saving Data for the Long Term.”

Here is an extract:

“Laboratory data may be in some proprietary format depending on the instrument on which they were generated. If this is the case, consider how the data can be read in years to come. It is neither practical nor feasible to maintain software programs that would enable these data to be read. It is highly unlikely that the software will still run on operating systems many years from now, nor will there be many operators who would know how to use the software. A potential solution may be to standardize the data, transferring it into a generic data format.

A key issue with archived data is maintaining a description or inventory of where the data belongs. Just because a file is named ‘injection 01 29 Oct 2011,’ this does not tell someone years from now that these data belong to the impurity profile for a stability sample for product xyz in month three for an accelerated study. How will you know what the data are, whether they are complete, and who created them and when? This demonstrates that there is no benefit in ‘dumping’ data in an archive--this must be done with the same diligence needed for archiving a paper document.”

For further details, see BioPharm

 Posted by Dr. Tim Sandle

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