TY - JOUR 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 DO - 10.5731/pdajpst.2018.008573 SP - pdajpst.2018.008573 AU - Deborah M. Autor AU - Zena Kaufman AU - Ron Tetzlaff AU - Maryann Gribbin AU - Madlene Dole AU - Derek Glover AU - Brad Mercer AU - Doreen Newhouse AU - Jackie Veivia-Panter AU - Anil Sawant AU - Denyse Baker Y1 - 2018/01/01 UR - http://journal.pda.org/content/early/2018/02/14/pdajpst.2018.008573.abstract N2 - 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. ER -