Data integrity and software validation: case study

  • At: 2018 FIP Congress in Glasgow (Scotland)
  • Type: Poster
  • By: FIGUEIREDO, Sara (LEF, Analytical, Quality Control and Validation Department)
  • Co-author(s): Duarte Santos: ANF Director, ANF , Lisbon, Portugal
    Fátima Carvalho: Executive and Technical Director, LEF, Lisbon, Portugal
    Ana Brízio: Analytical Department, LEF, Lisbon, Portugal
    Sara Dias Figueiredo: Analytical Department, LEF, Lisbon, Portugal
    Sofia Santos: Quality Assurance Department, LEF, Lisbon, Portugal
  • Abstract:

    Background

    Data integrity is an actual, global and pressing issue. Regulatory agencies are paying closer attention to this subject based on the evidence that data integrity-related GMP violations have been on the rise which can cause significant effects on the quality of process associated. Pharmaceutical industry has huge responsibility to deliver ..

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