Validation

preparation of (DQ/)IQ/OQ(/PQ) protocols and reports

(including discussion, check and approval by client's QA)

  • hardware layout and software design (DQ) (FAT)
  • documentation (IQ) (FAT and SAT)
  • automation hardware (IQ) (FAT and SAT)
  • operating platform and software installation (PLC,PCS,SCADA,OP,...) (IQ) (FAT and SAT)
  • electrical hardware of cabinets (IQ) (FAT and SAT)
  • electrical wiring and pneumatic hosing (IQ) (SAT)
  • measurement and control equipment (IQ) (SAT)
  • safety relevant components and operations (OQ) (FAT and SAT)
  • calibration of measurement and control equipment (OQ) (FAT and SAT)
  • signal- and line test (I/O level run-off and SCADA) (OQ) (FAT and SAT)
  • alarms and controls (sequence level run-off and SCADA) (OQ) (FAT and SAT)
  • custom built add-ons (sequence level run off and SCADA) (OQ) (FAT and SAT)
  • supplementary visualisation (operating panels) (OQ) (FAT and SAT)
  • safety relevant issues (alarm system) (OQ) (FAT and SAT)
  • unit operations (operation level run-off and SCADA) (OQ) (FAT and SAT)
  • batch and recipe management (operation level run off and SCADA/PCS) (OQ) (FAT and SAT)
  • automation system performance (PQ) (security, load, networks, time base, Y2K) (FAT and SAT)
  • automation system maintenance (PQ) (back up, restore, restart) (FAT and SAT)
  • change request and error magement

preparation of operator manual (English, German, French, Turkish)

  • automation and operation issues (visualisation, security...) and manual devices
  • security instructions
  • draft SOPs technological run-off control (technological unit operations with manual interventions)
  • draft SOP preventive maintenance
  • draft SOP trouble shooting and failure elimination
  • draft SOP shutdown and startup of installation
  • draft SOP calibration
  • draft SOP for backup, restore and restart (see above)

SAT Automation Software at client's site (SAT - Site Acceptance Test)

  • SAT of PLC/PCS, SCADA, OPs:
  • documented check of software design (DQ)
  • documented check of documentation (IQ)
  • documented check of operating platform and software installation (PLC,PCS,SCADA,OP,...) (IQ)
  • documented check of signal- and line test (I/O level run-off and SCADA) (OQ)
  • documented check of alarms and control (sequence level run-off and SCADA) (OQ)
  • documented check of custom built add-ons (sequence level run-off and SCADA) (OQ)
  • documented check of supplementary visualisation (operating panels) (OQ)
  • documented check of operation of safety relevant issues (alarm system) (OQ)
  • documented check of unit operations (operation level run off and SCADA) (OQ)
  • documented check of batch and recipe management (operation level run-off and SCADA) (OQ)
  • documented check of automation system performance (PQ)
  • documented check of automation system maintenance (PQ)

retrospective validation

  • study of installation
  • risk assessment
  • preparation of missing design documents
  • preparation of experience report

preparation of validation protocol and reports

  • execution of validation
  • preparation of final documentation
  • assembly of design, as built, validation according to GaMP guidelines and component documentation
  • preparation of overall spare parts list