RT Journal Article
SR Electronic
T1 PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.008573
DO 10.5731/pdajpst.2018.008573
A1 Deborah M. Autor
A1 Zena Kaufman
A1 Ron Tetzlaff
A1 Maryann Gribbin
A1 Madlene Dole
A1 Derek Glover
A1 Brad Mercer
A1 Doreen Newhouse
A1 Jackie Veivia-Panter
A1 Anil Sawant
A1 Denyse Baker
YR 2018
UL http://journal.pda.org/content/early/2018/02/14/pdajpst.2018.008573.abstract
AB PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.