RT Journal Article
SR Electronic
T1 Archiving Requirements for Electronic Pharmaceutical Manufacturing Documents and Associated Executable Software
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 306
OP 310
VO 48
IS 6
A1 Quinn, Thomas
YR 1994
UL http://journal.pda.org/content/48/6/306.abstract
AB Many pharmaceutical manufacturers are currently evaluating the feasibility of electronic batch record (EBR) and electronic document management (EDM) systems. Considerable effort has been invested in the design of the batch record files and electronic signature devices and procedures. Much less consideration has been given to the potential need for pharmaceutical manufacturers to be able to re-create the operational software environment necessary to review archived documents at some future date. The paper discusses methods, policies, and equipment that can be used to fulfill this function.