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