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Cloud solutions for GxP laboratories: considerations for data storage.
Davis, Scott; Usansky, Joel; Mitra-Kaushik, Shibani; Kellie, John; Honrine, Kimberly; Woolf, Eric; Adams, Jeb; Kelly, Ryan; Evens, John; Pine, Samuel; Hochreiner, Hannes; Dawes, Michelle; Kentner, Jason; Crawford, Sean.
Afiliación
  • Davis S; Information Technology, PPD, 2240 Dabney Road, Richmond, VA 23230, USA.
  • Usansky J; Research & Early Development, Bristol Myers Squibb, Princeton, NJ 08648, USA.
  • Mitra-Kaushik S; Bioanalytics-Genomic Medicine Unit, Sanofi, Framingham, MA 01701, USA.
  • Kellie J; Bioanalysis, Immunogenicity & Biomarkers, GSK, Collegeville, PA 19426, USA.
  • Honrine K; Automation Group, PPD, Richmond, VA 23230, USA.
  • Woolf E; PPDM - Regulated PK Bioanalytics, Merck & Co., West Point, PA 19486, USA.
  • Adams J; R&D Operations, Amgen, Inc., Thousand Oaks, CA 91320, USA.
  • Kelly R; R&D - Software, Sotax Corporation, Westborough, MA 01581, USA.
  • Evens J; Immunochemistry, PPD, Richmond, VA 23230, USA.
  • Pine S; Bioanalysis & Immunogenicity, Nanobody Research Platform, Ablynx NV, a Sanofi Company, 9052 Zwijnaarde, Belgium.
  • Hochreiner H; R&D Informatics, Merck KGaA, 64293 Darmstadt, Germany.
  • Dawes M; Nonclinical Disposition & Bioanalysis/Nonclinical Research & Development, Bristol Myers Squibb, Princeton, NJ 08648, USA.
  • Kentner J; Information Technology, KCAS Bioanalytical & Biomarker Services, Shawnee, KS 66216, USA.
  • Crawford S; Commercial Data Science, Business Insights & Analytics, Bristol Myers Squibb, Princeton, NJ 08648, USA.
Bioanalysis ; 13(17): 1313-1321, 2021 Sep.
Article en En | MEDLINE | ID: mdl-34515519
ABSTRACT
Challenges for data storage during drug development have become increasingly complex as the pharmaceutical industry expands in an environment that requires on-demand availability of data and resources for users across the globe. While the efficiency and relative low cost of cloud services have become increasingly attractive, hesitancy toward the use of cloud services has decreased and there has been a significant shift toward real-world implementation. Within GxP laboratories, the considerations for cloud storage of data include data integrity and security, as well as access control and usage for users around the globe. In this review, challenges and considerations when using cloud storage options for the storage of laboratory-based GxP data are discussed and best practices are defined.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Almacenamiento y Recuperación de la Información / Nube Computacional / Laboratorios Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Bioanalysis Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Almacenamiento y Recuperación de la Información / Nube Computacional / Laboratorios Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Bioanalysis Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos