Acceptance area,Acceptance criterion,Metric,Target or tolerance,Evidence required,Reviewer,Result,Deviation,Corrective action
Scope,Product process boundary and decision are approved,Scope approval,Approved before modelling,Signed pilot brief and system boundary,Customer model owner,Not assessed,,
Inputs,Critical model inputs have source owner date and quality status,Input traceability,100 percent of critical inputs,Source register and data-quality review,Quality reviewer,Not assessed,,
Mass balance,Overall mass balance closes at each required boundary,Mass closure,Customer-agreed tolerance,Stream table and residual report,Process engineer,Not assessed,,
Component balance,Product substrate metabolite and critical buffer balances reconcile,Component closure,Customer-agreed tolerance,Component balance report,Process development,Not assessed,,
Energy balance,Major heating cooling and sterilization duties reconcile,Energy residual,Customer-agreed tolerance,Energy balance and utility basis,Utilities engineer,Not assessed,,
Equipment,Major equipment sizes and duties match the approved basis,Capacity and duty deviation,Customer-agreed tolerance,Equipment register and data sheets,Plant engineer,Not assessed,,
Operating mode,Batch fed-batch perfusion or continuous logic reproduces the approved recipe,State and event match,All critical operations reproduced,Recipe comparison and event log,MSAT,Not assessed,,
Scheduling,Shared equipment rooms labour utilities cleaning and holds are finite-capacity scheduled,Conflict count,Zero unresolved hard conflicts,Schedule Gantt and resource occupancy,Manufacturing planning,Not assessed,,
Throughput,Annual throughput and utilization reconcile with the planning basis,Throughput deviation,Customer-agreed tolerance,Campaign assumptions and capacity report,Operations,Not assessed,,
Physical boundaries,Oxygen heat mixing metabolite osmolality and hold-time risks are evaluated,Boundary coverage,All agreed boundaries assessed,Boundary register and source basis,Process development,Not assessed,,
Economics,Materials consumables labour utilities waste CAPEX and facility assumptions are traceable,Cost coverage,All material cost drivers included,TEA workbook and source register,TEA reviewer,Not assessed,,
Uncertainty,Critical assumptions include ranges and sensitivity ranking,Sensitivity coverage,All agreed uncertain inputs,Intervals distributions and sensitivity output,Modelling lead,Not assessed,,
LCA,System boundary inventory and impact factors are documented,LCA inventory closure,All agreed flows mapped,LCA inventory and source basis,LCA reviewer,Not assessed,,
Scenario comparison,At least two process or operating scenarios are compared,Scenario count,At least 2 approved scenarios,Before-after comparison and branch history,Customer model owner,Not assessed,,
Traceability,Every model change is attributable and reviewable,Audit completeness,100 percent of accepted changes,Version branch and audit export,Quality reviewer,Not assessed,,
Exports,Workbook CSV SVG and complete package open in independent tools,Export success,100 percent of required exports,Automated test record and manual opening check,Independent reviewer,Not assessed,,
Limitations,Screening calculations and unvalidated assumptions are visibly labelled,Limitation coverage,All known limitations recorded,Readiness and gap report,Independent reviewer,Not assessed,,
Decision,The pilot answers the approved engineering question or identifies the exact missing evidence,Decision completeness,Approved by customer model owner,Decision memo and open-action list,Customer sponsor,Not assessed,,