Linda,
A validation of a system is never finished. If this is the concept
then you will find yourself sometime down the line with a
non-validated system.
The validation package is a living set of activities and documents.
Thus, if you have updates - include them in the package and be sure
that th package reflects the current state of the system.
As a matter of fact it is a good practice to review and update
documents like the URS and its derivatives and consequences all the
way through to testing scripts based on the accumulated changes
control requests.
Best regards,
Alex
___________________
Dr Alexander Gad
Director - QC and computerized systems
Quality - Global Generic resources
TEVA Pharmaceutical Industries
POBox 3190,
PetahTikva, 49131, Israel
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