{"id":"W6930659384","doi":"10.5281/zenodo.15109785","title":"Optimizing Quality System Procedures for Compliance and Efficiency for Pharmaceutical and Medical Device industries","year":2025,"lang":"en","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Fisheries and Aquaculture Studies","field":"Agricultural and Biological Sciences","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Medical device; Quality (philosophy); Audit; Quality management system; Product (mathematics); Pharmaceutical industry; Stakeholder; Quality assurance","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.1922753,0.0008620358,0.0008396875,0.004222143,0.003892051,0.01015659,0.002194958,0.002684442,0.003783589],"category_scores_gemma":[0.2387473,0.0006945156,0.001062793,0.003001064,0.004777591,0.006329314,0.005245643,0.003571763,0.001514011],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01114692,"about_ca_system_score_gemma":0.05788445,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006886278,"about_ca_topic_score_gemma":0.006132024,"domain_scores_codex":[0.7120697,0.1405217,0.02374407,0.007049663,0.1113564,0.005258552],"domain_scores_gemma":[0.6405384,0.122428,0.06916432,0.04382664,0.1205401,0.00350243],"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":[0.0006199808,0.002146771,0.06096118,0.00315361,0.0003406314,0.0002334573,0.01011841,0.02147207,0.0333148,0.1637359,0.01934736,0.6845558],"study_design_scores_gemma":[0.0007001541,0.009186336,0.1911888,0.01485849,0.0006487544,0.00140529,0.02181422,0.07973326,0.1515869,0.2336986,0.2940995,0.001079705],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.157149,0.005052117,0.721848,0.03106741,0.0006802997,0.008021744,0.0004949583,0.002063275,0.07362328],"genre_scores_gemma":[0.5462195,0.001670624,0.441804,0.003241031,0.0001832645,0.00200909,0.0003831257,0.0003175382,0.004171929],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.1922753,"threshold_uncertainty_score":0.9960684,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09276172793386003,"score_gpt":0.3183441724831315,"score_spread":0.2255824445492715,"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."}}