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 Autor, Deborah M.
A1 Kaufman, Zena
A1 Tetzlaff, Ron
A1 Gribbin, Maryann
A1 Dole, Madlene
A1 Glover, Derek
A1 Mercer, Brad
A1 Newhouse, Doreen
A1 Veivia-Panter, Jackie
A1 Sawant, Anil
A1 Baker, Denyse
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.