| d8bb98712db47532… | Positive POST /cxu [strict-1781312780938] | active | contextual | yes | |
| 0b4bc0f9d3c9f6b3… | Validation fixture — CxU with lifecycle history [fixture-1781312761647] | active | contextual | yes | |
| 169769f03834d30d… | QA validation test CXU for demo3 deployment verification | active | contextual | yes | |
| 1be71b8a2ee63c9c… | Action plans for CAPAs must be documented in the Enterprise Quality Management System (EQMS) and include specific owners and hard due dates for each action. | active | contextual | yes | |
| 2de341fe0a7c3c5d… | CAPAs categorized as Critical (Priority 1) require an investigation due in 15 days and a closure target of 60 days based on a Risk Priority Number (RPN) of 20 or greater. | draft | contextual | yes | |
| 4a615c3077275af1… | Upon identification of a CAPA, the Global Quality Coordinator (GQC) must perform a Risk Assessment using the Severity (S) x Occurrence (O) x Detectability (D) matrix to categorize the CAPA's priority level. | draft | contextual | yes | |
| eaec2863d0df13b0… | The Ishikawa (Fishbone) Diagram is mandatory for all Global CAPAs to evaluate the 6Ms: Man, Machine, Method, Material, Measurement, and Mother Nature (Environment) so that comprehensive root cause analysis can be conducted. | draft | contextual | yes | |
| 8dd051d2161b04c7… | The 5 Whys tool is required for initial drill-down into mechanical or procedural failures during the investigation of Global CAPAs so that root causes can be effectively identified. | draft | contextual | yes | |
| 4a058fa2c2212640… | Adverse Trends in the CAPA program are defined as three or more similar major deviations within a rolling 6-month period across different sites so that significant issues can be identified early. | draft | contextual | yes | |
| 874e903c65d2594b… | All records related to CAPAs must be maintained in the EQMS and in-progress CAPAs must be updated at least every 14 days by the CAPA Owner to ensure proper tracking and accountability. | draft | contextual | yes | |
| 91058df4c4472618… | The Effectiveness Verification (EV) Plan must be approved by the GQC before any actions are closed to ensure that the actions taken are effective. | draft | contextual | yes | |
| 11eb6c02a5b20f2b… | Action plans must be documented in the Enterprise Quality Management System (EQMS) and must differentiate between Correction, Corrective Action, and Preventive Action so that actions are clearly defined and tracked. | draft | contextual | yes | |
| ac74795caa2de44b… | All Global CAPAs require a multi-disciplinary investigation team and mandate the use of specific tools such as the 5 Whys, Ishikawa Diagram, and Barrier Analysis to ensure thorough investigation and root cause analysis. | draft | contextual | yes | |
| e626e4b6909d73fa… | The Risk Assessment for CAPA identification uses the Severity (S) x Occurrence (O) x Detectability (D) matrix to categorize issues into Critical, High, and Medium priorities so that appropriate response times and closure targets can be established. | draft | contextual | yes | |
| 2e76bd13cacf1c21… | Adverse trends are defined as three or more similar major deviations within a rolling 6-month period across different sites so that potential issues can be identified early. | draft | contextual | yes | |
| db4abcaebacfa61a… | The Global CAPA Owner is the assigned Subject Matter Expert (SME) responsible for the cross-functional investigation under the Global CAPA program so that local actions are synchronized with Site Quality Heads. | draft | contextual | yes | |
| 52ab8858dcf89d3b… | Correction involves immediate action taken to remediate a detected non-conformity, such as placing a batch in quarantine, to prevent further issues. | draft | contextual | yes | |
| 8647eb827ed195ba… | The Chief Quality Officer (CQO) serves as the final approval authority for all Critical (Priority 1) CAPAs and is required to sign any extension requests exceeding 180 total days. | draft | contextual | yes | |
| 35a112839473f8e1… | The Global Quality Council (GQC) is responsible for approving all Global CAPA Action Plans and Effectiveness Verification (EV) results to ensure compliance with quality standards. | draft | contextual | yes | |
| 8097f22bedbc230c… | The Global Quality Intelligence (GQI) team must continuously monitor inputs to the CAPA program, including adverse trends, external signals, and internal signals, to ensure timely identification of issues so that appropriate corrective actions can be implemented. | draft | contextual | yes | |
| f30801cc46f6a782… | Effectiveness Verification (EV) represents objective evidence gathered to confirm that the CAPA achieved its intended result without unintended consequences so that the integrity of the CAPA process is maintained. | draft | contextual | yes | |
| 8a5721029032e6a7… | Root Cause Analysis (RCA) is a systematic, data-driven process for identifying the underlying cause of a failure so that effective corrective actions can be implemented. | draft | contextual | yes | |
| 41b0d3c89a9f111f… | Preventive Action (PA) refers to action taken to eliminate the cause of a potential non-conformity based on trend data so that future non-conformities are avoided. | draft | contextual | yes | |
| d7ddd07de3126880… | Correction is defined as an immediate action taken to remediate a detected non-conformity, while Corrective Action (CA) is an action taken to eliminate the root cause of an existing non-conformity, and Preventive Action (PA) is taken to eliminate the cause of a potential non-conformity based on trend data. | draft | contextual | yes | |
| bf1442e574fd100c… | Compliance with the Global CAPA program is mandated by several regulations including 21 CFR Part 211.180/192 for records and reports of drug product failure investigations, 21 CFR Part 820.100 for Quality System Regulation for Corrective and Preventive Action, and EU GMP Volume 4, Chapter 1 for Quality Management. | draft | contextual | yes | |
| f36ea1bb57cbfe73… | The Global CAPA program applies to all corporate manufacturing facilities, research laboratories, and distribution centers operating under GxP regulations, specifically governing Global Quality Events which include events impacting multiple geographic regions or sites, Class I or Class II product recalls, critical audit findings from Regulatory Agencies, and systemic failures in the global Quality Management System. | draft | contextual | yes | |
| 57ad2e61f7eb7a53… | The Global Corrective and Preventive Action (CAPA) program aims to ensure that quality data is collected, analyzed, and investigated to identify the root cause of non-conformities under the framework established by the Global Quality Management Standard so that actions can be implemented to eliminate those causes and prevent recurrence. | draft | contextual | yes | |
| 33c6903b585de018… | Zeroth Agents, Inc. (ZAG) is a C-Corp incorporated under New Jersey Corp ID 010097987, operating as the active client-services subsidiary; it operates a Wells Fargo account ending 8091 and runs its own QuickBooks instance managed by Eric Tarnowski. | active | contextual | yes | |
| 448c5004e4740fa0… | Zeroth Technology, Inc. (ZT) is an S-Corp incorporated under New Jersey Corp ID 004717217, serving as the parent studio holding company for the Zeroth group; it operates a Wells Fargo account ending 8083 and runs a single QuickBooks instance managed by Jamey Canterbury. | active | contextual | yes | |
| 5ba77c4f3f8f1d47… | Zeroth Technology, Inc. is the parent studio holding company for three wholly-owned subsidiaries: Zeroth Agents, Inc., Zeroth Attest, Inc., and Zeroth Settlement Solutions, Inc. | active | absolute | yes | |
| 40dc8b9874d4e79f… | All records related to CAPAs must be maintained in the Enterprise Quality Management System (EQMS) and updated at least every 14 days by the CAPA Owner. | draft | contextual | yes | |
| e5ddfa9790e761f9… | The Enterprise Quality Management System (EQMS) is the required platform for documenting action plans in the CAPA process so that actions are tracked and managed efficiently. | draft | contextual | yes | |
| 7ab2faf196cc03a2… | The Ishikawa (Fishbone) Diagram is mandatory for all Global CAPAs and requires evaluation of the 6Ms: Man, Machine, Method, Material, Measurement, and Mother Nature (Environment) so that comprehensive root cause analysis can be conducted. | draft | contextual | yes | |
| e1c98c17a56adcd4… | The 5 Whys technique is required for initial drill-down into mechanical or procedural failures during Global CAPA investigations so that root causes can be effectively identified. | draft | contextual | yes | |
| 62e9b6ebc139da06… | The Risk Assessment in the CAPA program utilizes the Severity (S) x Occurrence (O) x Detectability (D) matrix to categorize issues into Critical, High, and Medium priorities so that appropriate response actions can be determined. | draft | contextual | yes | |
| f68eaec2ab64d448… | Adverse Trends in the CAPA program are defined as three or more similar major deviations occurring within a rolling 6-month period across different sites so that significant issues can be identified early. | draft | contextual | yes | |
| b892ca82f87aa118… | In-progress CAPAs must be updated at least every 14 days by the CAPA Owner so that the status of actions is current and monitored. | draft | contextual | yes | |
| a4c7e2b5729d8b8a… | All records related to CAPAs shall be maintained in the EQMS so that documentation is centralized and accessible. | draft | contextual | yes | |
| c7c3ef9450a8175d… | The Effectiveness Verification (EV) Plan must be approved by the GQC before any actions are closed so that the effectiveness of actions can be validated. | draft | contextual | yes | |
| eba0e3507517baaf… | Action plans must be documented in the Enterprise Quality Management System (EQMS) and must differentiate between Correction, Corrective Action, and Preventive Action so that actions are clearly defined and tracked. | draft | contextual | yes | |
| fd94a4ef4396a22d… | All Global CAPAs mandate a multi-disciplinary investigation team and require specific tools such as 5 Whys and Ishikawa Diagram for root cause analysis so that comprehensive investigations are conducted. | draft | contextual | yes | |
| 458af73feec199ce… | The GQC shall perform a Risk Assessment using the Severity (S) x Occurrence (O) x Detectability (D) matrix upon identification of CAPA inputs so that risks are prioritized for investigation. | draft | contextual | yes | |
| dc18484cb11c0061… | Internal signals consist of management review outcomes and significant audit non-conformances so that internal quality issues can be effectively tracked and managed. | draft | contextual | yes | |
| 4db75426bbde90f7… | External signals include regulatory inspection findings (FDA 483s) and customer complaints with safety implications so that the CAPA program can respond to critical external feedback. | draft | contextual | yes | |
| badedca5a3f1283b… | Adverse trends are identified as three or more similar major deviations within a rolling 6-month period across different sites so that potential issues can be addressed proactively. | draft | contextual | yes | |
| e56acdddc1c58d35… | Inputs to the CAPA program shall be continuously monitored by the Global Quality Intelligence (GQI) team so that adverse trends and signals can be promptly identified for action. | draft | contextual | yes | |
| 8b4773b9ef87dd3c… | The Chief Quality Officer (CQO) has final approval authority for all Critical (Priority 1) CAPAs and is the required signatory for any extension requests exceeding 180 total days so that critical actions are properly authorized. | draft | contextual | yes | |
| 855bd99084d031a7… | The Global CAPA Owner is the assigned Subject Matter Expert (SME) responsible for the cross-functional investigation and must liaise with Site Quality Heads to ensure local actions are synchronized so that the CAPA process is effectively managed. | draft | contextual | yes | |
| 7d0836505825bc26… | Effectiveness Verification (EV) is defined as the objective evidence gathered to confirm that the CAPA achieved its intended result without unintended consequences. | draft | contextual | yes | |
| 862d9dc0bdfe94ce… | Root Cause Analysis (RCA) is defined as a systematic, data-driven process for identifying the underlying cause of a failure. | draft | contextual | yes | |