tlhIngan-Hol Archive: Mon May 19 20:03:06 1997

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RE: jIqeqnIS



From:  David Trimboli (SuStel)

> [email protected] on behalf of Andeen, Eric wrote:

>> <<OpenBatch> wej DoD pagh, patHom wItI'bogh cha'>
>> wIchenmoHnIS. meqmeymo', pat chu'vaD <patHom wItI'bogh wInabbogh wa'>   
    

>> wIpong 'e' wIwuqlaw', 'ach jatlh ghotpu' law': <Doghqu' ghu'vam.   
pongvam
>> QIp law' Hoch QIp puS. pong nI'qu' wI'ogh>.

> jIyajbe'.  qatlh 'oHvaD "OpenBatch 3.1" bopongbe'?

'oHvaD "OpenBatch 3.1" wIpongchugh, 'oH lo'laHbe' Hergh malja'DIvI'mey.   
"FDA" chutmey Doghqu'mo', pat chu' lo'chugh Hergh malja'DIvI', chenmoHmeH   
mIw naQ tob malja'DIvI' 'e' poQ "FDA". 'ach "OpenBatch 3.1 Service Pack   
<n>" wIpongchugh, pat tI'lu' 'ej chu'be' 'e' qel "FDA".

SKI: FDA rules allow installation of maintenence releases in   
pharmaceutical plants with no fuss, but a software upgrade requires   
revalidation of the ENTIRE manufacturing process.

pagh  


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