Poll on 21 CFR Part 11

GMP News No. 268

GMP News
4 December 2002
 

Poll on 21 CFR Part 11

 
A poll on 21 CFR Part 11, conducted by NuGenesis, provides interesting information about the implementation of FDA requirements on electronic records and electronic signatures and the problems that pharmaceutical companies 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." As many as 27% believe that it will still take 7-10 years to reach this aim. And another 25% think that a paperless documentation is not feasible at all! 

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

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

One of the main reasons for the high cost lies certainly with the fact that many validation activities are necessary. Therefore, the efficient implementation of the Part-11 requirements is one of the main topics of two current ECA events.

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

Author: 
Oliver Schmidt
CONCEPT HEIDELBERG

   

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