The APV Guideline “Computerized Systems” based on Annex 11 of the EU-GMP Guideline-April 26, 1996
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES-5 April, 2007
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS-25 September 2007
Annex 11 Computerized Systems- June 30th, 2011(Deadline for coming into operation)
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES-1 September 2009
