RC-001 · Rev 0.2Effective 2026-11-06

Today's models aren't ready for regulated work. We help close the gap.

Benchmarks that show where they fall short,
and environments to train on that work.

The environment

We build companies. Not prompts: whole companies, with the files a regulator would ask for. Havenor Therapeutics has 789 of them, 120 colleagues, and the usual mess: superseded SOPs, executed copies, reports that disagree with their own protocols.

Exhibit AHavenor Therapeutics · 789 files
CAL-2024-4875 WSH-02 calibration certificate.pdfCAL-2026-4735 WSH-02 calibration certificate.pdfAVT-SOP-053_Preventive_Maintenance_Programme_v3.0.pdfAVT-SOP-058_Cleanroom_Cleaning_and_Sanitisation_v2.0.pdfAVT-SOP-059_Pest_Control_Programme_v5.0.pdfAVT-SOP-060_Compressed_Gas_Systems_v2.0.docxAVT-SOP-061 Water for Injection System Operation (v1.0).docxAVT-SOP-053 Preventive Maintenance Programme (v4.0) DRAFT.docxAVT-SOP-056 Utility System Monitoring (v3.0) DRAFT.docxSOP-054 Instrument Calibration.docxSOP-055 Facility Environmental Control.docxSOP-056 Utility System Monitoring.docxSOP-057 Work Permit and Contractor Control.docxSOP-053 Preventive Maintenance Programme.docxSOP-055 Facility Environmental Control.pdfSOP-056 Utility System Monitoring.pdfMTH-CCI-003_Container_closure_integrity_by_vacuum_decay_v3.0.docxMTH-HPLC-011_Assay_by_isocratic_HPLC_v3.0.docxMTH-HPLC-012_Impurities_by_gradient_HPLC_v3.0.docxMTH-HPLC-022_Kelvoran_related_substances_by_HPLC_v3.0.docxMTH-MIC-001_Sterility_by_membrane_filtration_v3.0.docxMTH-PHY-004_pH_by_potentiometry_v3.0.docxMTH-PHY-009_Osmolality_by_freezing-point_depression_v3.0.docxMTH-PHY-015_Sub-visible_particulate_matter_by_light_obscuration_v3.0.docxMTH-VIS-002_Appearance_by_visual_inspection_v3.0.docxAVT-RS-069.docxAVT-RS-076.docxAVT-RS-079.docxAVT-RS-084.docxAVT-RS-101.docxAVT-VAL-338.docxAVT-VAL-344.docxAVT-VAL-347.docxAVT-VAL-348.pdfAVT-VAL-350.pdfAVT-VAL-355.docxAVT-VAL-358.docxMER-2025-6108.pdfMER-2025-6402.pdfMER-2026-6799.docxMER-2026-7741.docxMER-2026-8014.docxMER-2026-8830.docxMER-2026-9014.docxMER-2026-9221.pdfAVT-SOP-016_Out_of_Specification_Investigation_v2.0.pdfAVT-SOP-018 Reference Standard Management (v2.0).docxAVT-SOP-019 Laboratory Reagent and Solution Control (v5.0).docxAVT-SOP-021_Sampling_of_Starting_Materials_v4.0.docxAVT-SOP-022 Environmental Monitoring of Classified Areas (v3.0).docxAVT-SOP-023_Microbiological_Media_Preparation_and_Growth_Promotion_v1.0.docxAVT-SOP-024_Stability_Programme_Administration_v3.0.docxAVT-SOP-026_Retention_Sample_Management_v1.0.docxAVT-SOP-028 Sterility Testing by Membrane Filtration (v2.0).docxAVT-SOP-029_Laboratory_Investigation_of_Aberrant_Results_v4.0.docxAVT-SOP-030 Column Performance Monitoring (v5.0).docxAVT-SOP-028 Sterility Testing by Membrane Filtration (v3.0) DRAFT.docxSOP-017 Analytical Method Transfer.pdfSOP-020 Analytical Instrument Qualification.docxSOP-025 Chromatographic Data System Review.pdfSOP-027 Bacterial Endotoxin Testing.docxAVT-SOP-019_Laboratory_Reagent_and_Solution_Control_v4.0.docxAVT-SOP-022_Environmental_Monitoring_of_Classified_Areas_v2.0.pdfAVT-SPEC-018_AVI-401_Release_and_Stability_Specification.docxAVT-SPEC-022_AVI-355_Release_and_Stability_Specification.docxAVT-SPEC-022_AVI-355_Release_and_Stability_Specification_v3.0_SUPERSEDED.docxAVI-401_Accelerated_and_Intermediate_Results.xlsxAVT-STB-102-A4_Qualified_State_of_the_Testing_Chain.docxAVT-STB-301_AVI-401_Interim_Stability_Report.pdfAVT-STB-302_AVI-401_Interim_Stability_Report.pdfAVT-STB-341_AVI-355_Interim_Stability_Report.pdfAVT-STB-342_AVI-355_Interim_Stability_Report.pdfAVT-STB-301-A1_Representative_Chromatograms.pdfSTB-AVI355-011_Accelerated_Results.xlsxSTB-AVI355-012_Long_Term_Results.xlsxSTB-AVI401-002_Long_Term_Results.xlsxSTB-AVI401-002_Study_Status.xlsxAVT-STB-301-A2_Stability_Trend_Figures.pdfAVI401_Filter_Container_Control_Summary.pdfAVT-SOP-033_Media_Fill_Process_Simulation_v4.0.docxAVT-SOP-034_Compounding_of_Parenteral_Solutions_v4.0.docxAVT-SOP-035_Sterile_Filtration_Operations_v1.0.docxAVT-SOP-036 Aseptic Filling Line Operation (v4.0).pdfAVT-SOP-037_In-Process_Control_Sampling_v5.0.docxAVT-SOP-038_Product_Changeover_and_Cleaning_v5.0.docxAVT-SOP-039 Manufacturing Batch Record Completion (v3.0).docxAVT-SOP-040 Hold Time Management (v1.0).docxAVT-SOP-041_Visual_Inspection_of_Filled_Units_v2.0.pdfAVT-SOP-042_Yield_Reconciliation_v4.0.pdfAVT-SOP-043_Personnel_Qualification_for_Aseptic_Areas_v5.0.pdfAVT-SOP-031 Aseptic Gowning and Behaviour (v3.0) DRAFT.docxAVT-SOP-037 In-Process Control Sampling (v6.0) DRAFT.docxAVT-SOP-039 Manufacturing Batch Record Completion (v4.0) DRAFT.docxSOP-031 Aseptic Gowning and Behaviour.pdfSOP-032 Line Clearance.docxAVT-SOP-034_Compounding_of_Parenteral_Solutions_v3.0.docxSOP-031 Aseptic Gowning and Behaviour.pdfSOP-033 Media Fill Process Simulation.docx2026-06-17 Change Control Board minutes.docx2026-07-01 Change Control Board minutes.docx2026-07-19 Change Control Board minutes.docx2026-08-01 Change Control Board minutes.docx2026-08-16 Change Control Board minutes.docx2026-08-26 Change Control Board minutes.docx2026-09-13 Change Control Board minutes.docx2025-12-29 Quality Council minutes.docx2026-01-29 Quality Council minutes.docx2026-02-27 Quality Council minutes.docx2026-03-31 Quality Council minutes.docx2026-04-26 Quality Council minutes.docx2026-05-26 Quality Council minutes.docx2026-06-28 Quality Council minutes.docx2026-07-25 Quality Council minutes.docx2026-08-28 Quality Council minutes.docx2026-02-28 Site Leadership Review minutes.docx2026-03-29 Site Leadership Review minutes.docx2026-04-30 Site Leadership Review minutes.docx2026-05-26 Site Leadership Review minutes.docx2026-06-28 Site Leadership Review minutes.docx2026-07-25 Site Leadership Review minutes.docx2026-08-27 Site Leadership Review minutes.docx2025-04-01 Stability Review minutes.docx2025-05-31 Stability Review minutes.docx2025-08-01 Stability Review minutes.docx2025-09-29 Stability Review minutes.docx2025-11-28 Stability Review minutes.docx2026-01-27 Stability Review minutes.docx2026-03-31 Stability Review minutes.docx2026-05-29 Stability Review minutes.docx2026-07-27 Stability Review minutes.docx2024-07-07 Supplier Performance Review minutes.docx2024-10-04 Supplier Performance Review minutes.docx2025-01-02 Supplier Performance Review minutes.docx2025-04-02 Supplier Performance Review minutes.docx2025-07-04 Supplier Performance Review minutes.docx2025-09-30 Supplier Performance Review minutes.docx2025-12-27 Supplier Performance Review minutes.docx2026-03-29 Supplier Performance Review minutes.docx2026-06-26 Supplier Performance Review minutes.docx2026-07-25 Technical Operations Standup minutes.docx2026-08-02 Technical Operations Standup minutes.docx2026-08-06 Technical Operations Standup minutes.docx2026-08-14 Technical Operations Standup minutes.docx2026-08-21 Technical Operations Standup minutes.docx2026-08-28 Technical Operations Standup minutes.docx2026-09-03 Technical Operations Standup minutes.docx2026-09-11 Technical Operations Standup minutes.docx2026-09-20 Technical Operations Standup minutes.docx2026-03-28 Validation Steering minutes.docx2026-04-30 Validation Steering minutes.docx2026-05-28 Validation Steering minutes.docx2026-06-27 Validation Steering minutes.docx2026-07-28 Validation Steering minutes.docx2026-08-24 Validation Steering minutes.docxAVT-SOP-076 Packaging Component Specification Control (v1.0).pdfAVT-SOP-077 Artwork and Labelling Control (v5.0) DRAFT.docxAVT-SOP-078 Serialisation and Aggregation (v2.0) DRAFT.docxSOP-077 Artwork and Labelling Control.docxSOP-078 Serialisation and Aggregation.docxSOP-079 Packaging Line Setup and Verification.docxAVT-SOP-090 Adverse Event Intake and Triage (v4.0).docxAVT-SOP-091_Periodic_Safety_Report_Preparation_v4.0.docxAVT-SOP-092 Signal Detection and Evaluation (v1.0).docxCC-2018-001_Change_of_secondary_packaging_carton_supplier_v1.0.docxCC-2019-001_Requalification_of_CHM-40-02_following_major_maintenance_v1.0.pdfCC-2019-002_Replacement_of_LYO-01_controller_with_current_vendor_model_v1.0.pdfCC-2019-003_Extension_of_AVI-355_bulk_hold_time_v1.0.pdfCC-2019-004_Addition_of_AVI-355_to_the_site_registration_v1.0.docxCC-2020-001_Addition_of_a_second_supplier_for_Cleanroom_garment_and..._v1.0.pdfCC-2020-002_Relocation_of_retention_samples_to_the_new_store_v1.0.pdfCC-2020-003_Requalification_of_CHM-40-02_following_major_maintenance_v1.0.docxCC-2020-004_Introduction_of_automated_visual_inspection_on_LN-02_v1.0.pdfCC-2021-001_Introduction_of_automated_visual_inspection_on_LN-01_v1.0.docxCC-2021-002_Revision_of_cleaning_agent_concentration_for_LN-03_v1.0.docxCC-2021-003_Revision_of_AVI-105_release_specification_limits_v1.0.docxCC-2021-004 Update of environmental monitoring locations in QC-03 (v1.0).docxCC-2021-005 Replacement of CHM-40-02 controller with current vendor... (v1.0).docxCC-2022-001 Change of secondary packaging carton supplier (v1.0).docxCC-2022-002 Relocation of retention samples to the new store (v1.0).docxCC-2022-003 Replacement of DPT-01 controller with current vendor model (v1.0).docxCC-2023-001 Extension of AVI-330 bulk hold time (v1.0).pdfCC-2023-002 Introduction of automated visual inspection on LN-01 (v1.0).docxCC-2023-003 Addition of AVI-508 to the site registration (v1.0).pdfCC-2023-004 Revision of AVT-DMS user access review frequency (v1.0).pdfCC-2023-005 Requalification of HPLC-02 following major maintenance (v1.0).docxCC-2023-006 Requalification of CHM-25-03 following major maintenance (v1.0).pdfCC-2024-001 Relocation of retention samples to the new store (v1.0).pdfCC-2024-002 Upgrade of AVT-ERP to vendor release supported by the s... (v1.0).pdfCC-2024-003 Revision of cleaning agent concentration for LN-03 (v1.0).pdfCC-2025-001 Requalification of VES-03 following major maintenance (v1.0).docxCC-2025-002 Replacement of INC-01 controller with current vendor model (v1.0).pdfCC-2026-001 Introduction of automated visual inspection on LN-02 (v1.0).docxCC-2026-002 Addition of a second supplier for Secondary overwrap su... (v1.0).pdfCC-2026-003 Revision of cleaning agent concentration for LN-01 (v1.0).docxCC-2026-004 Introduction of automated visual inspection on LN-02 (v1.0).pdfCC-2026-005 Relocation of retention samples to the new store (v1.0).pdfCC-2026-006 Revision of AVT-SCADA-02 user access review frequency (v1.0).pdfCC-AVI401-017_Change_Status.xlsxChange Control Register.xlsxDEV-2020-001_Differential_pressure_alarm_in_GR-02_not_acknowledged_w..._v1.0.docxDEV-2021-001_Environmental_monitoring_excursion_in_GR-02_v1.0.pdfDEV-2021-002_Label_reconciliation_discrepancy_at_end_of_packaging_run_v1.0.pdfDEV-2021-003_Environmental_monitoring_excursion_in_GR-02_v1.0.docxDEV-2021-004_Balance_out_of_calibration_tolerance_at_periodic_check_v1.0.pdfDEV-2021-005_Differential_pressure_alarm_in_GR-08_not_acknowledged_w..._v1.0.pdfDEV-2021-006_Audit_trail_review_not_completed_within_the_defined_per..._v1.0.pdfDEV-2021-007 Balance out of calibration tolerance at periodic check (v1.0).pdfDEV-2021-008 Environmental monitoring excursion in GR-03 (v1.0).pdfDEV-2021-009 Audit trail review not completed within the defined per... (v1.0).docxDEV-2021-010 Balance out of calibration tolerance at periodic check (v1.0).docxDEV-2022-001 Preventive maintenance overdue on VES-02 (v1.0).docxDEV-2022-002 Filling stopped for 71 minutes during AVI-355 batch (v1.0).docxDEV-2022-003 Label reconciliation discrepancy at end of packaging run (v1.0).pdfDEV-2022-004 Audit trail review not completed within the defined per... (v1.0).docxDEV-2022-005 Environmental monitoring excursion in GR-04 (v1.0).pdfDEV-2022-006 Environmental monitoring excursion in GR-03 (v1.0).pdfDEV-2022-007 Temperature excursion in INC-01 during power interruption (v1.0).pdfDEV-2023-001 Audit trail review not completed within the defined per... (v1.0).docxDEV-2023-002 Sample stored outside the specified condition prior to... (v1.0).pdfDEV-2023-003 Label reconciliation discrepancy at end of packaging run (v1.0).pdfDEV-2023-004 Incoming material received without the supplier certifi... (v1.0).docxDEV-2023-005 Audit trail review not completed within the defined per... (v1.0).docxDEV-2023-006 Differential pressure alarm in GR-06 not acknowledged w... (v1.0).docxDEV-2023-007 Incoming material received without the supplier certifi... (v1.0).docxDEV-2023-008 Filling stopped for 28 minutes during AVI-355 batch (v1.0).pdfDEV-2024-001 Temperature excursion in CHM-40-01 during power interru... (v1.0).pdfDEV-2024-002 Incoming material received without the supplier certifi... (v1.0).pdfDEV-2024-003 Balance out of calibration tolerance at periodic check (v1.0).pdfDEV-2024-004 Temperature excursion in CHM-30-01 during power interru... (v1.0).pdfDEV-2024-005 Sample stored outside the specified condition prior to... (v1.0).pdfDEV-2024-006 Environmental monitoring excursion in GR-04 (v1.0).docxDEV-2024-007 Balance out of calibration tolerance at periodic check (v1.0).docxDEV-2025-001 Gowning qualification expired for one operator (v1.0).pdfDEV-2025-002 Differential pressure alarm in GR-08 not acknowledged w... (v1.0).docxDEV-2025-003 Balance out of calibration tolerance at periodic check (v1.0).pdfDEV-2025-004 Differential pressure alarm in QC-01 not acknowledged w... (v1.0).pdfDEV-2026-001 Environmental monitoring excursion in QC-03 (v1.0).docxDEV-2026-002 Filling stopped for 60 minutes during AVI-401-PFS batch (v1.0).pdfDEV-2026-003 Environmental monitoring excursion in GR-08 (v1.0).pdfDEV-2026-004 Environmental monitoring excursion in GR-02 (v1.0).docxDEV-2026-005 Preventive maintenance overdue on WSH-02 (v1.0).docxDEV-2026-006 Audit trail review not completed within the defined per... (v1.0).pdfDEV-2026-007 Audit trail review not completed within the defined per... (v1.0).pdfDEV-2026-008 Batch record entry made without contemporaneous signature (v1.0).pdfDeviation and CAPA Register.xlsxAVT-SOP-086_Document_Lifecycle_Management_v4.0.docxAVT-SOP-087_Training_Programme_Administration_v5.0.pdfAVT-SOP-088 Good Documentation Practice (v3.0).docxAVT-SOP-089_Curriculum_Assignment_and_Requalification_v1.0.pdfAVT-SOP-088 Good Documentation Practice (v4.0) DRAFT.docxAVT-SOP-088_Good_Documentation_Practice_v2.0.pdfSOP-086 Document Lifecycle Management.pdfLAB-INV-2025-014_AVI-355_Accelerated_Atypical_Result_Investigation.pdfAVT-SOP-001_Deviation_Management_v2.0.pdfAVT-SOP-002_Corrective_and_Preventive_Action_v5.0.docxAVT-SOP-003_Change_Control_v4.0.pdfAVT-SOP-004 Batch Record Review and Product Disposition (v1.0).pdfAVT-SOP-005 Annual Product Quality Review (v3.0).docxAVT-SOP-006_Management_of_Quality_Risk_v3.0.pdfAVT-SOP-009 Handling of Product Complaints (v2.0).pdfAVT-SOP-010 Recall and Field Action (v2.0).pdfAVT-SOP-012 Control of Quality Records (v4.0).docxAVT-SOP-013 Product Quality Agreement Management (v3.0).pdfAVT-SOP-014_Data_Integrity_Governance_v5.0.docxAVT-SOP-015 Vendor Notification of Change (v4.0).pdfAVT-SOP-002 Corrective and Preventive Action (v6.0) DRAFT.pdfAVT-SOP-005 Annual Product Quality Review (v4.0) DRAFT.pdfAVT-SOP-008 Supplier Qualification and Monitoring (v5.0) DRAFT.pdfSOP-007 Internal Audit Programme.pdfSOP-008 Supplier Qualification and Monitoring.docxSOP-011 Quality Management Review.pdfAVT-SOP-003_Change_Control_v3.0.pdfAVT-SOP-009_Handling_of_Product_Complaints_v1.0.docxAVT-SOP-014_Data_Integrity_Governance_v4.0.pdfAVT-RS-088_Report_Narrative_v1.0.docxAVT-RS-093_Report_Narrative_v1.0.docxHA-AVI401-IR-2026-014_Information_Request.pdf3.2.P.8_Stability_Summary.docxAVT-SOP-072_Health_Authority_Commitment_Tracking_v2.0.docxAVT-SOP-073_Submission_Document_Preparation_v3.0.pdfAVT-SOP-074 Post-Approval Change Reporting Categorisation (v1.0).docxAVT-SOP-075_Regulatory_Intelligence_Review_v3.0.docxSOP-071 Regulatory Change Assessment.docxSOP-073 Submission Document Preparation.docxCAL_data (24-12-2025).csvEM_data (21-07-2025).csvSTAB_data (11-05-2025).csvSTAB_data (16-06-2026).csvSTAB_data (24-09-2025).csvTRAIN_data (30-12-2025).csvYIELD_data (12-10-2024).csvYIELD_data (17-05-2025).csvcal_export_20260215.csvcal_export_20260731.csvem pull for review.csvexport202504100000.csvexport202512160000.csvexport202512260000.csvexport202602110000.csvoos pull for review (2).csvoos pull for review.csvoos_export_20250322.csvstab pull for review (2).csvstab pull for review (3).csvstab pull for review.csvstab_export_20260221.csvtrain_export_20251227.csvyield_export_20250202.csvyield_export_20250224.csvyield_export_20250805.csvAVT-VAL-352_extract.xlsxMER-2025-5512_extract.xlsxAVT-SOP-062 Material Receipt and Quarantine (v2.0).pdfAVT-SOP-064_Cold_Chain_Distribution_v2.0.docxAVT-SOP-065_Inventory_Cycle_Counting_v2.0.docxAVT-SOP-066_Shipment_of_Finished_Product_v2.0.docxAVT-SOP-064 Cold Chain Distribution (v3.0) DRAFT.docxSOP-063 Warehouse Storage and Segregation.pdfAVT-SOP-062_Material_Receipt_and_Quarantine_v1.0.pdfAVT-SOP-066_Shipment_of_Finished_Product_v1.0.docxAVT-SOP-067_Supplier_Audit_Execution_v2.0.pdfAVT-SOP-068_Incoming_Material_Inspection_v2.0.pdfAVT-SOP-069_Supplier_Corrective_Action_Requests_v1.0.pdfAVT-SOP-068 Incoming Material Inspection (v3.0) DRAFT.pdfSOP-070 Approved Supplier List Maintenance.docxAVT-SOP-067_Supplier_Audit_Execution_v1.0.pdfHFC-QN-2026-074_HF-55_Film_Notification.pdfCoA 0012024301.pdfCoA 0012025104.pdfCoA 0012026314.pdfCoA 0012026501.pdfCoA 0012026529.pdfCoA 0012026843.pdfCoA 0022024206.pdfCoA 0022025353.pdfCoA 0022025601.pdfCoA 0022026283.pdfCoA 0022026647.pdfCoA 0032024701.pdfCoA 0032025230.pdfCoA 0032025461.pdfCoA 0032025582.pdfCoA 0032025996.pdfCoA 0032026298.pdfCoA 0042024405.pdfCoA 0042026139.pdfCoA 0042026246.pdfCoA 0052024136.pdfCoA 0052024649.pdfCoA 0052026137.pdfCoA 0052026839.pdfCoA 0052026886.pdfCoA 0062025183.pdfCoA 0062025646.pdfCoA 0062026390.pdfCoA 0072024242.pdfCoA 0072024832.pdfCoA 0072025518.pdfCoA 0082024400.pdfCoA 0082024406.pdfCoA 0082024975.pdfCoA 0082025928.pdfCoA 0082025945.pdfCoA 0082026460.pdfCoA 0092024133.pdfCoA 0092024659.pdfCoA 0092025186.pdfCoA 0092025754.pdfCoA 0092026256.pdfCoA 0092026281.pdfCoA 0102025265.pdfCoA 0102025491.pdfCoA 0102026290.pdfCoA 0102026520.pdfCoA 0112024304.pdfCoA 0112024920.pdfCoA 0112025384.pdfCoA 0112025671.pdfCoA 0112025788.pdfCoA 0112026193.pdfCoA 0122024212.pdfCoA 0122024687.pdfCoA 0122025603.pdfCoA 0122025673.pdfCoA 0122025853.pdfCoA 0122025893.pdfCoA 0132024141.pdfCoA 0132024286.pdfCoA 0132024797.pdfCoA 0132025672.pdfCoA 0132025810.pdfCoA 0132026399.pdfCoA 0142025126.pdfCoA 0142025308.pdfCoA 0142025895.pdfCoA 0142026207.pdfCoA 0142026742.pdfCoA 0152024448.pdfCoA 0152026109.pdfCoA 0152026729.pdfCoA 0162025483.pdfCoA 0162025640.pdfCoA 0162026306.pdfCoA 0162026635.pdfCoA 0172024158.pdfCoA 0172024290.pdfCoA 0172025166.pdfCoA 0172025393.pdfAVT-VAL-104_Filter_Chemical_Compatibility_Validation_Report.pdfAVT-VAL-105_Filter_Extractables_and_Leachables_Assessment_Report.pdfAVT-VAL-106_Filter_Wetting_and_Integrity_Validation_Report.pdfAVT-VAL-107_Sterilising_Filter_Bacterial_Retention_Validation_Report.pdfAVT-VAL-201_Flexible_Container_Compatibility_Validation_Report.pdfAVT-VAL-202_Container_Closure_Seal_Integrity_Validation_Report.pdfAVT-VAL-203_Administration_Set_Compatibility_Validation_Report.pdfAVT-VAL-104-P_Executed_Copy_003.pdfAVT-VAL-105-P_Executed_Copy_003.pdfAVT-VAL-106-P_Executed_Copy_003.pdfAVT-VAL-107-P_Executed_Copy_003.pdfAVT-VAL-104-P_Filter_Chemical_Compatibility_Validation_Protocol_v01.docxAVT-VAL-104-P_Filter_Chemical_Compatibility_Validation_Protocol_v01.pdfAVT-VAL-105-P_Filter_Extractables_and_Leachables_Assessment_Protocol_v01.docxAVT-VAL-105-P_Filter_Extractables_and_Leachables_Assessment_Protocol_v01.pdfAVT-VAL-106-P_Filter_Wetting_and_Integrity_Validation_Protocol_v01.docxAVT-VAL-106-P_Filter_Wetting_and_Integrity_Validation_Protocol_v01.pdfAVT-VAL-107-P_Sterilising_Filter_Bacterial_Retention_Validation_Protocol_v01.docxAVT-VAL-107-P_Sterilising_Filter_Bacterial_Retention_Validation_Protocol_v01.pdfPR-BMS-001_Periodic_Review_2020_v1.0.docxPR-BMS-002 Periodic Review 2022 (v1.0).docxPR-BMS-003 Periodic Review 2023 (v1.0).docxPR-BMS-004 Periodic Review 2026 (v1.0).docxVAL-408 Validation Summary AVT-BMS.docxPR-CAL-001_Periodic_Review_2020_v1.0.pdfPR-CAL-002 Periodic Review 2022 (v1.0).pdfPR-CAL-003 Periodic Review 2024 (v1.0).docxPR-CAL-004 Periodic Review 2026 (v1.0).docxVAL-413 Validation Summary AVT-CAL.docxAVT-VAL-406_Validation_Summary_AVT-CDS_v1.0.pdfPR-CDS-001_Periodic_Review_2019_v1.0.docxPR-CDS-002 Periodic Review 2022 (v1.0).docxPR-CDS-003 Periodic Review 2024 (v1.0).docxPR-CDS-004 Periodic Review 2026 (v1.0).docxPR-DMS-001_Periodic_Review_2020_v1.0.docxPR-DMS-002 Periodic Review 2022 (v1.0).pdfPR-DMS-003 Periodic Review 2024 (v1.0).docxPR-DMS-004 Periodic Review 2025 (v1.0).pdfVAL-403 Validation Summary AVT-DMS.docxAVT-VAL-416 Validation Summary AVT-ELN (v1.0).docxAVT-VAL-407_Validation_Summary_AVT-EMS_v1.0.docxPR-EMS-001_Periodic_Review_2019_v1.0.pdfPR-EMS-002 Periodic Review 2022 (v1.0).docxPR-EMS-003 Periodic Review 2024 (v1.0).docxPR-EMS-004 Periodic Review 2026 (v1.0).docxPR-ERP-001_Periodic_Review_2019_v1.0.docxPR-ERP-002 Periodic Review 2022 (v1.0).docxPR-ERP-003 Periodic Review 2025 (v1.0).pdfVAL-404 Validation Summary AVT-ERP.docxAVT-VAL-414_Validation_Summary_AVT-LBL_v1.0.docxPR-LBL-001_Periodic_Review_2021_v1.0.pdfPR-LBL-002 Periodic Review 2024 (v1.0).docxPR-LIMS-042_Periodic_Review_2019_v1.0.pdfPR-LIMS-043 Periodic Review 2021 (v1.0).docxPR-LIMS-044 Periodic Review 2024 (v1.0).pdfPR-LIMS-045 Periodic Review 2025 (v1.0).pdfVAL-400 Validation Summary AVT-LIMS.pdfAVT-VAL-401_Validation_Summary_AVT-MES_v1.0.docxPR-MES-001_Periodic_Review_2020_v1.0.pdfPR-MES-002 Periodic Review 2022 (v1.0).docxPR-MES-003 Periodic Review 2023 (v1.0).pdfPR-MES-004 Periodic Review 2026 (v1.0).docxAVT-VAL-402_Validation_Summary_AVT-QMS_v1.0.docxPR-QMS-001_Periodic_Review_2020_v1.0.docxPR-QMS-002 Periodic Review 2022 (v1.0).docxPR-QMS-003 Periodic Review 2026 (v1.0).docxAVT-VAL-405_Validation_Summary_AVT-RIM_v1.0.pdfPR-RIM-001_Periodic_Review_2020_v1.0.docxPR-RIM-002 Periodic Review 2024 (v1.0).pdfPR-SCADA-01-001_Periodic_Review_2020_v1.0.docxPR-SCADA-01-002 Periodic Review 2021 (v1.0).docxPR-SCADA-01-003 Periodic Review 2023 (v1.0).docxPR-SCADA-01-004 Periodic Review 2026 (v1.0).docxVAL-409 Validation Summary AVT-SCADA-01.docxAVT-VAL-410_Validation_Summary_AVT-SCADA-02_v1.0.pdfPR-SCADA-02-001_Periodic_Review_2020_v1.0.pdfPR-SCADA-02-002 Periodic Review 2023 (v1.0).docxPR-SCADA-02-003 Periodic Review 2025 (v1.0).pdfAVT-VAL-415_Validation_Summary_AVT-SPC_v1.0.docxPR-SPC-001 Periodic Review 2023 (v1.0).docxPR-SPC-002 Periodic Review 2025 (v1.0).pdfAVT-VAL-411_Validation_Summary_AVT-TMS_v1.0.docxPR-TMS-001_Periodic_Review_2020_v1.0.pdfPR-TMS-002 Periodic Review 2023 (v1.0).docxPR-TMS-003 Periodic Review 2026 (v1.0).pdfPR-WMS-001_Periodic_Review_2020_v1.0.pdfPR-WMS-002 Periodic Review 2022 (v1.0).pdfPR-WMS-003 Periodic Review 2026 (v1.0).docxVAL-412 Validation Summary AVT-WMS.docxAVT-SOP-080 Access Control and Periodic Access Review (v4.0).pdfAVT-SOP-081_Electronic_Records_and_Signatures_v3.0.pdfAVT-SOP-082 System Backup and Restoration (v4.0).docxAVT-SOP-083_Infrastructure_Qualification_v3.0.docxAVT-SOP-084_Audit_Trail_Review_v4.0.docxAVT-SOP-085_Disaster_Recovery_Testing_v2.0.docxAVT-SOP-083 Infrastructure Qualification (v4.0) DRAFT.docxAVT-SOP-080 Access Control and Periodic Access Review (v3.0).docxSOP-084 Audit Trail Review.docxAVT-SOP-045_Equipment_Qualification_Lifecycle_v2.0.docxAVT-SOP-046_Cleaning_Validation_v2.0.docxAVT-SOP-047 Process Validation Lifecycle (v3.0).docxAVT-SOP-048 Computerized System Validation (v3.0).docxAVT-SOP-049_Sterilization_Process_Validation_v1.0.docxAVT-SOP-050 Container Closure Integrity Validation (v3.0).docxAVT-SOP-051 Requalification and Periodic Review (v5.0).docxAVT-SOP-052 Validation Deviation Handling (v4.0).pdfAVT-SOP-051 Requalification and Periodic Review (v6.0) DRAFT.docxSOP-044 Validation Master Planning.docxAVT-SOP-045_Equipment_Qualification_Lifecycle_v1.0.docxAVT-SOP-046_Cleaning_Validation_v1.0.pdfAVT-SOP-048 Computerized System Validation (v2.0).docxSOP-044 Validation Master Planning.docx
The Havenor file tree, one line per file. Highlighted: the two reports a single validation check turns on.

Then an expert gives a model a real assignment. In Task 03: review the sterile-filter validation and write the brief an inspector will read.

The model wrote a fluent brief and caught a 30-minute window the approved protocol never contained. Here is a check it missed.

The grading
Exhibit BHavenor · Task 03 · 3 of 13
  1. AVT-VAL-106 · Wetting & integrity report

    Limits: bubble point NLT 3.45 bar, diffusive flow NMT 18.0 mL/min. Criterion 5: “Integrity result remains correlated to the bacterial-retention qualification.”

    ?Correlated by what?

  2. AVT-VAL-107 · Bacterial retention report

    Bubble point before and after challenge on three filter lots. No diffusive-flow result.

    §The only retention evidence.

  3. Model's brief · Claude Opus 5.5 · Claude Code

    “Bubble point ≥3.45 bar / diffusion ≤18.0 mL/min are valid release limits”

    ✗Credited both limits. Only one is tied to retention.

Published v0.2 run. Inspect Task 03 run ↗ · v0.1 write-up →

Nothing in that line reads wrong. It is wrong because a criterion signed Pass is not the evidence behind it. Every task we write turns on a judgment like this, and every criterion is checked by someone who has made it for a living.

At scale

Biopharma Bench V0.2: 81 tasks across 24 companies, 1045 criteria, grouped by the kind of work. Each bar is one task; full height means every criterion met.

Exhibit CBiopharma Bench V0.2
Reg38
Clin14
CMC11
Dev8
PV5
QA5
All
  1. 1GPT-6 Astra

    61.4%

    56.9%

    53.0%

    61.7%

    50.2%

    64.1%

    59.5%
  2. 2Claude Fable 5.1

    62.4%

    58.2%

    54.8%

    52.3%

    52.8%

    59.7%

    58.9%
  3. 3GPT-6.1 Sol

    61.5%

    53.9%

    56.5%

    61.4%

    56.4%

    59.1%

    58.8%
  4. 4Grok 4.7

    54.5%

    46.0%

    52.0%

    61.3%

    52.1%

    62.3%

    54.0%
  5. 5Grok 4.6

    54.9%

    46.2%

    59.4%

    49.3%

    47.8%

    59.6%

    53.4%
  6. 6DeepSeek V4.1 Flash

    49.9%

    51.3%

    46.5%

    55.2%

    55.9%

    61.1%

    51.0%
  7. 7Claude Opus 5.5

    52.6%

    56.4%

    43.7%

    44.2%

    40.4%

    59.9%

    50.2%
  8. 8GLM-5.3 Flash

    46.9%

    40.6%

    39.0%

    40.9%

    40.0%

    30.0%

    42.6%
  9. 9GPT-6.1 Terra

    40.3%

    31.8%

    29.7%

    41.3%

    26.9%

    45.3%

    37.1%
Full leaderboard →

The best model, GPT-6 Astra, scores 59.5% on the average task. It finishes 1 of 81 tasks. No model does better.

The gap is not between labs. DeepSeek V4.1 Flash, an open model, scores 51.0%; Claude Opus 5.5 scores 50.2%. The gap is between all of them and the work.

What we supply

We build where the record system is the problem: biopharma dossiers and EPC project packs.

Exhibit DDeployment, evaluation, and post-training
01DeploymentDomain workflows across biopharma (CMC, quality, regulatory, clinical) and energy & EPC (submittal disposition, MDR/ITP, turnover).☐
02EvaluationYour data or ours: component task families and end-to-end role seats, co-built with your experts and our Fellows for offline regression and online monitoring.☐
03Post-training, OTS data & strategyArchitecture diagnosis, containerized RL environments with isolated verifiers, coupled partial-credit rubrics, SFT reference deliverables, and licensed corpora.☐
Verticals: Biopharma, Medical devices, Energy & EPC. Public benchmarks. Expert review: AI Fellows.
Next step

Tell us what you need to measure.

A lab, an AI company, or an expert who wants to write tasks.

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All measurements: one run per task (k=1), reasoning effort high.