Computerized systems engineering, quality, compliance

Most complex and GxP systems validation


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