December 2009


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Subscribe PSDGLIST Cindy Ready <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 3 Dec 2009 12:07:47 -0500
text/plain (47 lines)

I am in an R&D environment and have a monitoring system, that has changed 
several times:  manual collections, a couple of different electronic monitoring 
systems, changes in configuration of the system, etc... and therefore, I have 
data from several different sources.  

Because of these changes I have the following questions:
1.  What are your polices for keeping/maintaining Temperature, Humidity and 
Light Environmental data?  
2.  How long do you keep/maintain the data?  
3.  If you change monitoring systems/equipment, how long would you maintain 
the legacy data?  
4.  How would you maintain legacy data? 
5.  Who maintains the legacy data? 
6.  If you get rid of a chamber, how long do you maintain the data from that 
7.  If you moved to a new facility, how long would you maintain the data from 
the previous facility? 
8.  Who decided what your policy would be and where is the policy 

Any answers to these questions, as well as any other information or 
observations, would be greatly appreciated, 

Cindy Ready
[log in to unmask]
Senior Scientist II
Stability Sample Processing

Alcon Laboratories
6201 South Freeway
Forth Worth, TX 76134

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