Computerized systems engineering, quality, compliance

Most complex and GxP systems validation

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The GxP validation process of the computer or automated systems designed by PHARMASYS to insure Data Integrity includes the following steps:

  • Quality assurance support on the projects
  • Compliance audit : Data Integrity, Part 11, GxP’s, BPx, ISO13485, iec62304 and Compliance implementation
  • Suppliers audit
  • Specifications to GAMP format : URS, functional (FS), software and hardware conception (HDS and SDS)
  • Validation plan, validation reports
  • Risk analysis, matrix of traceability
  • Qualifications (QC, Check QI/QQ/QP)
  • Infrastructure qualifications following the best practices ITIL and GAMP
  • Periodical reviews
  • Operational procedures and qualified maintenance