Bioequivalence and Bioavailability Forum

Hi tarak,

in the early days of spreadsheets a few issues were identified (e.g. in relation to SD calculation for non.biological data) which caused some people to conclude that all spreadsheets are useless etc.
There are many nuances. Like you I also believe spreadsheets have their place and most of the early issues have been well weeded out, not least because of opensource spreadsheets that had safer calculations.

❝ who should do spreadsheet validation? user department or QA ?

As per your SOP.
May be your clinical department, your metrology department, IT, or someone else.

❝ what should be role of user department and QA in spreadsheet validation in GCP environment?

As per your SOP. Usually QA approve plans, reports and do checks.

❝ what all validation document required?

What di you mean here?

❝ Do we need to validate dose calculation sheet for clinical study?

Of course not, unless you think the dose somehow is important in relation to safety, efficacy or the subject's well-being.