title: PDA Points To Consider: Fundamental Concepts in Data Integrity.
authors.affiliation: Director, Corporate Quality Assurance, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA; buhlmann@amgen.com.
authors.forename: Bob
authors.initials: B
authors.lastname: Buhlmann
authors.affiliation: DI Program Lead and Head of Strategic Planning and Operations Group QA, Novartis; and.
authors.forename: Madlene
authors.initials: M
authors.lastname: Dole
authors.affiliation: Consultant, ZGK Consulting.
authors.forename: Zena
authors.initials: Z
authors.lastname: Kaufmann
mesh_terms: D012107:Research Design