{"id":"W4317951950","doi":"10.5731/pdajpst.2021.012672","title":"Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation","year":2023,"lang":"en","type":"article","venue":"PDA Journal of Pharmaceutical Science and Technology","topic":"Advanced Statistical Process Monitoring","field":"Decision Sciences","cited_by":8,"is_retracted":false,"has_abstract":true,"ca_institutions":"Pfizer (Canada)","funders":"","keywords":"Standardization; Pharmaceutical industry; Computer science; Risk analysis (engineering); Pharmaceutical manufacturing; Process validation; Automation; Process (computing); Product testing; Biochemical engineering; Reliability engineering; Manufacturing engineering; Operations management; New product development; Business; Engineering; Medicine; Marketing","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.1003588,0.001737567,0.001452563,0.006127318,0.002116767,0.008630125,0.003712136,0.003206623,0.001164613],"category_scores_gemma":[0.05267204,0.001337628,0.001258204,0.00272376,0.009571917,0.005004549,0.008459503,0.005196206,0.001370447],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005343778,"about_ca_system_score_gemma":0.01882209,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003084749,"about_ca_topic_score_gemma":0.003937931,"domain_scores_codex":[0.8856227,0.06659807,0.006388959,0.004130206,0.03543491,0.00182509],"domain_scores_gemma":[0.9266785,0.03222441,0.007568833,0.008685427,0.02359308,0.001249646],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001834252,0.0009719298,0.01062943,0.004186613,0.0001701967,0.0008244736,0.01250185,0.008416669,0.04298049,0.07581171,0.00544757,0.8378756],"study_design_scores_gemma":[0.0004552105,0.01496259,0.05381053,0.02341446,0.0007060707,0.006441738,0.03281959,0.04336789,0.2155905,0.1697634,0.4372763,0.001391765],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.02676056,0.008582964,0.9270897,0.006235256,0.0003497651,0.007137564,0.0001722965,0.001396215,0.02227565],"genre_scores_gemma":[0.06860553,0.004443938,0.9213489,0.0009399073,0.00008798415,0.001790391,0.0001770989,0.0001535566,0.002452752],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.1003588,"threshold_uncertainty_score":0.5307545,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2595155019297749,"score_gpt":0.5278364085013488,"score_spread":0.2683209065715739,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}