Poll on 21 CFR Part 11

GMP News No. 268

GMP News
4 December 2002
 

Pollon 21 CFR Part 11

 
A poll on 21 CFR Part 11, conducted by NuGenesis, provides interestinginformation about the implementation of FDA requirements on electronicrecords and electronic signatures and the problems that pharmaceuticalcompanies encounter in trying to fulfil this task.

The question when the systems of their own organisation will become paperless was answered by 63% with "5-7 years." Asmany as 27% believe that it will still take 7-10 years to reach thisaim. And another 25% think that a paperless documentation is not feasibleat all! 

What is also analysed are the reasons forthe time-consuming implementation. 
The answers include:

  • not enough resources (46%),
  • the cost of transition is tooexpensive (32%) and
  • the technologies are not available(29%).

One of the main reasons for the high costlies certainly with the fact that many validation activities are necessary.

If you would like to see the completepoll, please click here.

Author: 
Oliver Schmidt
CONCEPT HEIDELBERG

   

 

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