CQV CSV CAI Datasheet 2026
Equipment can pass qualification and still carry computerized-system, data-integrity and automation gaps that delay release. CAI brings CQV and CSV together before testing begins. Requirements, system boundaries, supplier evidence and release needs are addressed through one coordinated strategy so equipment and computerized functions move toward controlled manufacturing use together. OPERATIONAL READINESS Equipment qualification and computerized-system evidence support a coordinated release decision. QUALIFIED IS NOT THE FINISH LINE INTEGRATED CQV + CSV WHEN CQV AND CSV RUN SEPARATELY THE RESULT: REPEATED WORK, LATE CHANGES AND UNRESOLVED RELEASE DEPENDENCIES Duplicate testing Alarms, controls, sequences and operator interfaces are tested by multiple teams. CQV: Equipment + process • Installation and physical systems • Equipment and process functions • Utilities and operating conditions Late computerized system gaps Audit trails, user access, time synchronization, backup and recovery surface after procurement. CAI Integrated verification • Shared requirements • Defined system boundaries • One risk-informed test strategy • Supplier evidence evaluated for reuse Unclear ownership Equipment functions, auto- mation logic and electronic records fall between CQV and CSV scopes. CSV: Software + automation + data • Configured functions and control logic • Electronic records and data integrity • Interfaces and supporting infrastructure
PLAN VERIFICATION BEFORE TESTING • Define requirements early. Address intended use, critical aspects and data-integrity needs before design and procurement decisions are fixed. • Set boundaries from the architecture. Assign equipment, software, automation and data functions to CQV, CSV or shared verification. • Build one verification strategy. Connect requirements, risk, traceability and test ownership across supplier, FAT, SAT and site activities. SUPPORT A MORE DIRECT PATH TO RELEASE • Reduce repeated testing by deciding where supplier and commissioning evidence may be reused. • Identify computerized-system and data-integrity gaps while designs can still be changed. • Consider qualification status, validation evidence, open issues and system changes in the release decision. WHY CAI • Our combined CQV, CSV and automation experience connects equipment operation with computerized functionality. • Process control and OT knowledge supports PLC, DCS, SCADA, historian and hybrid architectures. • Architecture-based boundary methods address control modules, equipment functions, phase logic, recipes and parameters. • Hands-on support carries the strategy through testing, issue resolution and release. Connect the work before execution Talk with CAI about bringing CSV, CQV and automation into one Operational Readiness strategy before testing gaps, duplicated effort or unresolved release dependencies affect startup. ARE YOU READY? +1 317 271 6082 | CAIReady.com INTEGRATED CQV + CSV CAI integrates planning across equipment, automation and computerized functions from requirements through release. Automated manufacturing systems combine physical equipment, pro - cess functions, control logic and electronic records. CAI treats them as one operating system while defining where CQV and CSV responsibili - ties differ. Requirements, risks and evidence are coordinated across the lifecycle rather than reconciled after testing begins. AT A GLANCE • One system: Equipment, automation, software and data are planned as parts of the same manufacturing system. • One verification strategy: CQV and CSV responsibilities, requirements and evidence are coordinated before testing begins. • One coordinated path to release: Qualification, validation evidence and open issues inform readiness for operational use.