Reference datasets 2 [Software]
Hi all,
now that reference datasets have been produced and published with (hopefully correct) reference results by some BE wackos I wonder about software PQ.
It can be argued that a system -in this case the computer doing the BE analysis- needs to be kept updated on several fronts and protected from undesired pertubations. It quickly becomes the eternal discussion of isolation versus options of updating. Noone really knows and can control well what goes on when you hook up a computer with e.g. Windows to the internet. There is absolutely no good way of telling the system that any traffic that could cause interference with SAS or WinNonlin or Minesweeper is prohibited while internet connections for good cause is required. You never know if the next anti-virus update screws up a dll of some other software without the user having a chance to know. Restricting access thorugh the fireall for some programs doesn't solve it. And so forth.
So I wonder wouldn't it be very solid and a good idea to simply perform some degree of PQ "every day" or "immediately before" a reported analysis; spend 30 secs literally on running the reference datasets through the stats package, compare the output and tick off the results, and then if the results match conclude that the system is PQ that day and run the necessary analysis?
Would be a minute or two of extra work on the day of analysis, and would require an extra form and possibly a sentence or two in a SOP. And we'd all sleep better.
No?
Edit: Category changed. [Helmut]
now that reference datasets have been produced and published with (hopefully correct) reference results by some BE wackos I wonder about software PQ.
It can be argued that a system -in this case the computer doing the BE analysis- needs to be kept updated on several fronts and protected from undesired pertubations. It quickly becomes the eternal discussion of isolation versus options of updating. Noone really knows and can control well what goes on when you hook up a computer with e.g. Windows to the internet. There is absolutely no good way of telling the system that any traffic that could cause interference with SAS or WinNonlin or Minesweeper is prohibited while internet connections for good cause is required. You never know if the next anti-virus update screws up a dll of some other software without the user having a chance to know. Restricting access thorugh the fireall for some programs doesn't solve it. And so forth.
So I wonder wouldn't it be very solid and a good idea to simply perform some degree of PQ "every day" or "immediately before" a reported analysis; spend 30 secs literally on running the reference datasets through the stats package, compare the output and tick off the results, and then if the results match conclude that the system is PQ that day and run the necessary analysis?
Would be a minute or two of extra work on the day of analysis, and would require an extra form and possibly a sentence or two in a SOP. And we'd all sleep better.
No?
Edit: Category changed. [Helmut]
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Reference datasets 2ElMaestro 2014-10-11 13:34 [Software]
- Templates In Phoenix/WinNonlin Helmut 2014-10-17 17:23
- Templates In Phoenix/WinNonlin jalgorta 2015-05-05 22:45
- Bug or feature? Helmut 2015-05-05 23:00
- Templates In Phoenix/WinNonlin ElMaestro 2015-05-06 01:00
- Templates In Phoenix/WinNonlin jalgorta 2015-05-06 13:45
- Windows locale? Helmut 2015-05-06 17:55
- Templates In Phoenix/WinNonlin jalgorta 2015-05-06 13:45
- Templates In Phoenix/WinNonlin SDavis 2018-05-02 15:46
- Templates In Phoenix/WinNonlin jalgorta 2015-05-05 22:45
- Templates In Phoenix/WinNonlin Helmut 2014-10-17 17:23