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.