Validation Determination Standard
Standard ID: VDTS
OriginID: OOF-OID-AI-VALIDOS-VDTS-2026-08-11-0008
Architecture: VALIDOS™ — Validation Governance Architecture
Category: AI & Interpretation
Subcategory: Validation Governance
Type: Parent Standard
Governed Space: Validation Determination
Version: 1.0
Status: Canonical · Open Standard
Effective Date: 11 August 2026
Compatibility: OOF® Methodology OS™ · GOA™ · OBIDENITY® · INTEGROS®
· ORA™ · AGA™ · AIG® · CLIA® · MGIA™ · ASGA™ · RIS™
AI-Readable: Yes
Authority: OOF®
Protection: MIP® — Methodological Intellectual Property
Canonical Language: English (UCL™)
Canonical Definition Extension
Validation execution produces results.Results alone do not create a legitimate validation conclusion.
A validation process may generate:
- measurements,
- test outputs,
- statistical findings,
- expert assessments,
- observations,
- simulations,
- criterion outcomes,
- contradictory findings,
- unresolved uncertainty,
- execution limitations,
- and residual deviations.
These elements must be interpreted within the governed structure
established by VALIDOS™.
Validation Determination Standard therefore governs
the transformation:
Governed Validation Record → Validation Finding → Criterion
Determination → Integrated Validation Determination
VDTS establishes the conditions necessary to determine:
- which execution results may legitimately participate in determination,
- which Validation Criteria have sufficient determination basis,
- whether individual criteria are satisfied,
- not satisfied,
- conditionally satisfied,
- or not determinable,
- how multiple criterion outcomes interact,
- how mandatory and non-mandatory criteria differ,
- how contradictory findings are treated,
- how uncertainty affects determination,
- how residual execution limitations propagate,
- whether evidence and source conditions constrain interpretation,
- whether determination must be scoped or conditional,
- whether sufficient basis exists for an overall determination,
- and what the governed validation record actually demonstrates.
VDTS does not create a permanent Validation State.
It does not authorize operational reliance.
It determines the validation conclusion supported by the governed
validation record.
Purpose
The purpose of Validation Determination Standard is to preventvalidation conclusions from being reduced to:
- raw test scores,
- simple pass/fail labels,
- majority voting,
- selective evidence,
- favorable averages,
- ungoverned expert opinion,
- arbitrary weighting,
- or conclusions broader than the validation process can legitimately support.
VDTS creates the interpretive governance layer between:
Validation Execution and:
Validation State
It ensures that a validation conclusion represents what the governed
validation process actually demonstrates—not what stakeholders hoped
it would demonstrate.
Governance Objective
VDTS establishes a governed Validation Determination frameworkcapable of producing conclusions that are:
- criterion-grounded,
- evidence-aware,
- source-aware,
- execution-aware,
- scope-bounded,
- uncertainty-aware,
- conflict-aware,
- limitation-aware,
- methodologically proportionate,
- traceable,
- and suitable for later Validation State assignment.
The standard seeks to ensure that:
- only determination-ready execution enters conclusion formation,
- criterion outcomes remain distinguishable,
- critical criteria retain appropriate significance,
- missing information is not converted into failure or success,
- contradictory results remain visible,
- uncertainty is preserved,
- conditional findings remain conditional,
- determination scope cannot exceed executed scope,
- invalid execution portions do not silently contribute,
- aggregation remains methodologically justified,
- and every Validation Determination can be reconstructed from the validation record supporting it.
Operational Role
Validation Determination Standard serves as the formal conclusionlayer of the VALIDOS™ validation lifecycle.
The preceding standards establish:
Validation Object → Validation Purpose & Scope → Validation Criteria
→ Validation Method → Validation Evidence Fitness → Validation
Source Reliability → Validation Execution
VDTS then asks:
What does that complete governed validation record
actually demonstrate?
Its structural progression is:
Determination-Ready Execution → Result Qualification → Criterion
Determination → Conflict & Uncertainty Integration → Cross-Criterion
Interpretation → Overall Determination → Validation
Determination Record
The resulting determination can then progress into Validation
State governance.
Governance Scope
Validation Determination Standard governs:- validation-result qualification,
- determination basis,
- criterion-level determination,
- criterion satisfaction,
- criterion non-satisfaction,
- conditional satisfaction,
- non-determinability,
- mandatory criterion treatment,
- critical criterion treatment,
- cross-criterion interpretation,
- determination aggregation,
- determination hierarchy,
- contradictory findings,
- determination conflict,
- uncertainty integration,
- limitation integration,
- residual execution impact,
- evidence-condition propagation,
- source-condition propagation,
- determination scope,
- partial determination,
- conditional determination,
- negative determination,
- indeterminate determination,
- overall Validation Determination,
- determination authority where applicable,
- determination traceability,
- determination change,
- and determination reassessment.
Validation Determination Basis
A Validation Determination should be derived from a sufficientlygoverned determination basis.
This may include:
- Validation Object reference,
- Validation Purpose,
- actual Validation Scope,
- Validation Depth,
- Validation Criteria,
- applicable thresholds,
- acceptance and rejection conditions,
- Validation Method Framework,
- Evidence Fitness information,
- Source Reliability information,
- Validation Execution Record,
- Execution Completeness status,
- Execution Conformity status,
- execution outputs,
- residual deviations,
- unresolved exceptions,
- limitations,
- conflicts,
- uncertainty,
- and Determination Readiness.
The determination basis defines what information may legitimately
support the validation conclusion.
Determination-Ready Execution
VDTS should consume only execution that is sufficiently readyfor determination.
This may include:
Determination Ready
or:
Determination Conditionally Ready
execution.
Where execution is:
Determination Not Ready
or:
Determination Blocked
VDTS should not manufacture a substantive validation conclusion
unsupported by the execution basis.
Execution Quality and Object Outcome Are Different
VALIDOS™ maintains:Execution Conformity ≠ Validation Success
A perfectly conformant validation may demonstrate that the
Validation Object fails.
Conversely:
Execution Invalidity ≠ Object Invalidity
Invalid execution may prevent VALIDOS™ from knowing whether the
object satisfies the Validation Criteria.
VDTS therefore interprets object outcomes only from execution
capable of legitimately supporting them.
Validation Result Qualification
Not every result generated during execution should automaticallycontribute to determination.
A result may be:
- valid for determination,
- conditionally usable,
- limited in scope,
- superseded,
- affected by deviation,
- affected by unreliable source conditions,
- methodologically incomparable,
- or unusable.
VDTS governs which execution results form the legitimate
determination basis.
Criterion Determination
Every applicable Validation Criterion should receive an explicitdetermination where sufficient basis exists.
Possible criterion-level outcomes may include: Criterion Satisfied
The governed validation record sufficiently demonstrates
satisfaction of the criterion under the applicable conditions.
Criterion Conditionally Satisfied
The criterion is satisfied only within explicit limitations,
assumptions, boundaries, operating conditions, or other
governed restrictions.
Criterion Not Satisfied
The governed validation record sufficiently demonstrates that the
required criterion condition has not been satisfied.
Criterion Not Determinable
The governed validation record does not provide sufficient
legitimate basis to determine whether the criterion is satisfied or
not satisfied.
These outcomes remain distinct.
Not Determinable Is a Legitimate Outcome
VALIDOS™ establishes:Insufficient basis for determination ≠ Criterion failure
and:
Insufficient basis for determination ≠ Criterion satisfaction
Where the validation record cannot legitimately answer the criterion
question, the correct outcome is:
Criterion Not Determinable
This prevents uncertainty from being converted into false certainty.
Criterion Satisfaction
Criterion Satisfaction must remain connected to:- the exact criterion,
- threshold where applicable,
- acceptance conditions,
- actual execution outputs,
- evidence,
- applicable source conditions,
- scope,
- object version,
- and relevant limitations.
A satisfied criterion should therefore be reconstructable rather
than asserted.
Criterion Non-Satisfaction
A criterion should be classified as Not Satisfied only where thegoverned validation record provides sufficient basis to
demonstrate non-satisfaction.
Absence of evidence is not automatically evidence of failure.
Therefore:
No Proof of Satisfaction ≠ Proof of Non-Satisfaction
Conditional Criterion Determination
A criterion may be satisfied only under conditions such as:- defined operating range,
- limited population,
- specific system version,
- restricted environment,
- continued mitigation,
- additional monitoring,
- limited time period,
- or another governed boundary.
Conditional determination must preserve those conditions.
Mandatory Criteria
Some Validation Criteria may be designated mandatory.Where a mandatory criterion is:
Not Satisfied
or in some validation contexts:
Not Determinable
the overall Validation Determination may be constrained regardless
of favorable results elsewhere.
The exact consequence must be established through the Validation
Criteria governance structure.
VDTS does not invent mandatory status retrospectively.
Criterion Weighting
Some validation frameworks may legitimately assign differentsignificance to different criteria.
Where weighting is used, VDTS requires that weighting be:
- established before outcome interpretation where reasonably possible,
- justified,
- traceable,
- methodologically relevant,
- and resistant to post-hoc manipulation.
Weighting should not be altered merely because the resulting
conclusion is inconvenient.
Aggregation Is Not Averaging
VALIDOS™ establishes:Cross-Criterion Determination ≠ Arithmetic Average
Different criteria may represent:
- mandatory conditions,
- critical conditions,
- supporting conditions,
- independent conditions,
- hierarchical conditions,
- conditional conditions,
- or exclusionary conditions.
Aggregation must preserve their governance meaning.
Cross-Criterion Interpretation
VDTS determines how multiple criterion outcomes collectivelycontribute to the overall Validation Determination.
Relevant questions may include:
- Are all mandatory criteria satisfied?
- Are any critical criteria not satisfied?
- Are material criteria not determinable?
- Do conditional outcomes restrict scope?
- Do criterion conflicts remain?
- Can partial validation be legitimately separated?
- Does one exclusionary condition override otherwise favorable findings?
Determination Hierarchy
Complex Validation Objects may require hierarchical determination.For example:
Module Determination → Subsystem Determination →
System Determination
or:
Criterion → Criterion Group → Validation Domain →
Overall Determination
VDTS permits hierarchical structure where the relationships remain
explicit and methodologically justified.
Partial Determination
A Validation Object may support a legitimate conclusion for part ofits Validation Scope while another part remains undetermined
or fails.
Where boundaries can be reliably separated, VDTS may permit:
Partial Positive Determination
Partial Negative Determination
Partial Conditional Determination
or: Partial Indeterminate Determination
This prevents unnecessary all-or-nothing conclusions.
Determination Scope
Every Validation Determination must remain bounded to the scopeactually supported by validation.
The determination should not extend beyond:
- validated object version,
- tested population,
- evaluated environment,
- executed scenarios,
- applicable operational state,
- validated jurisdiction,
- or another material boundary.
VALIDOS™ establishes:
Determination Scope ≤ Legitimately Executed Validation Scope
Determination and Validation Depth
The strength of a determination depends partly upon the ValidationDepth achieved.
A conclusion supported by exploratory validation should not
automatically be represented as equivalent to one supported by
high-assurance validation.
VDTS therefore preserves the relationship between determination and
achieved Validation Depth.
Contradictory Findings
Different execution results may support conflicting interpretations.VDTS requires material contradiction to remain visible.
Contradiction may arise from:
- different methods,
- different environments,
- different populations,
- different object states,
- different evidence,
- different sources,
- measurement variation,
- or genuine object instability.
Determination Conflict
A Determination Conflict exists where legitimate validation findingssupport materially incompatible criterion or overall conclusions.
Conflict may require:
- additional analysis,
- additional validation,
- method comparison,
- evidence review,
- source review,
- scope separation,
- conditional determination,
- or an indeterminate result.
Conflict should not be resolved merely by selecting the
preferred outcome.
Uncertainty Does Not Automatically Block Determination
Some uncertainty is compatible with legitimate validation.The relevant question is whether remaining uncertainty is acceptable
for the applicable Validation Criterion, Purpose, Depth, and
determination type.
VDTS therefore supports proportionate uncertainty governance.
Determination Conditions
An overall Validation Determination may be conditional.Conditions may include:
- restricted use,
- specific configuration,
- specific population,
- defined operating range,
- continued control,
- continued monitoring,
- limited time,
- supplementary validation,
- or another boundary.
These conditions become important inputs to Validation
State governance.
Overall Validation Determination
VDTS may establish overall determination classes such as:Positive Validation Determination
The governed validation record sufficiently demonstrates
satisfaction of the required Validation Criteria for the defined
scope and conditions.
Conditional Validation Determination
The governed validation record supports a positive determination
only within explicit conditions, limitations, restrictions, or
reduced scope.
Negative Validation Determination
The governed validation record sufficiently demonstrates
non-satisfaction of one or more criteria whose governance
significance prevents a positive determination for the
defined scope.
Indeterminate Validation Determination
The governed validation record does not provide sufficient
legitimate basis to establish either a positive or negative
overall determination.
Partial Validation Determination Different governed portions of the
Validation Object, criteria set, or Validation Scope legitimately
support different determination outcomes.
These classifications represent the validation conclusion.
They are not yet the persistent Validation State.
Positive Determination Is Not Reliance Authorization
VALIDOS™ establishes:Positive Validation Determination ≠ Authorization to Rely
A system may receive a positive determination while reliance remains
restricted because of:
- time,
- operational context,
- regulatory authority,
- risk,
- changed environment,
- or other governance conditions.
Reliance belongs to the tenth Parent Standard.
Negative Determination Is Not Universal Invalidity
A Negative Validation Determination applies to the ValidationObject, scope, criteria, version, and conditions actually assessed.
It should not automatically be generalized to every use or
future version.
Indeterminate Determination Is Not Failure
An Indeterminate Validation Determination means:VALIDOS™ does not possess sufficient governed basis to establish the
required conclusion.
It does not automatically mean the object is valid.
It does not automatically mean the object is invalid.
This is a legitimate methodological outcome.
Partial Determination
A Partial Validation Determination may be necessary where:- some criteria are satisfied,
- some criteria fail,
- some are indeterminate,
- some scope areas were not executed,
- or distinct components legitimately support different outcomes.
Partial determination should preserve those boundaries explicitly.
Determination Authority
Where formal determination requires an identifiable authority, VDTSmay govern:
- who or what may issue the determination,
- scope of determination authority,
- required independence,
- required competence,
- and authority conditions.
VDTS does not create legal or regulatory authority where
none exists.
Automated Determination
A Validation Determination may be partially or fully automated wheregovernance permits.
Automated determination may require:
- deterministic rules,
- governed aggregation logic,
- explicit criterion mapping,
- controlled thresholds,
- system identity,
- versioning,
- exception handling,
- and human escalation where required.
Automation must not make determination logic opaque.
AI-Assisted Determination
AI may assist in:- evidence synthesis,
- conflict detection,
- uncertainty identification,
- criterion mapping,
- traceability analysis,
- or determination drafting.
However, the governing determination structure must
remain reconstructable.
AI-generated reasoning should not silently replace the approved
determination logic.
Determination Traceability
A formal Validation Determination should be traceable through:Validation Object
↓
Validation Criteria
↓
Validation Method
↓
Evidence
↓
Sources
↓
Execution Activities
↓
Execution Outputs
↓
Criterion Determinations
↓
Overall Validation Determination
This creates the conclusion chain of VALIDOS™.
Validation Determination Record
A formal Validation Determination Record may preserve:- Determination Identifier,
- Validation Object,
- object version,
- Validation Purpose,
- actual Validation Scope,
- achieved Validation Depth,
- applicable Validation Criteria,
- criterion-level outcomes,
- mandatory criterion status,
- critical criterion status,
- execution basis,
- evidence basis,
- source conditions,
- conflicts,
- uncertainty,
- residual limitations,
- determination conditions,
- overall Validation Determination,
- determination authority where applicable,
- effective date,
- and sufficient traceability.
Determination Basis Transparency
The determination should permit a qualified reviewer to understandwhy the conclusion was reached.
This does not require exposing confidential intellectual property or
unrestricted internal reasoning.
It requires sufficient methodological transparency to reconstruct
the governed basis of the conclusion.
Determination Change Governance
A Validation Determination may require reassessment when:- execution records change,
- evidence changes,
- Source Reliability changes,
- a previously unknown deviation is discovered,
- criterion interpretation is corrected,
- methodological error is identified,
- or another material validation fact changes.
Determination Withdrawal
A determination may be withdrawn where its methodological basis ismaterially destroyed.
Possible triggers include:
- invalid execution,
- compromised evidence,
- major source failure,
- critical methodological error,
- wrong Validation Object,
- or another fundamental defect.
Withdrawal concerns the determination.
It does not by itself establish the object's current Validation
State after reassessment.
Determination Continuity
Validation Determinations should remain historicallyconnected across:
- corrections,
- revisions,
- revalidations,
- system updates,
- object versions,
- and later Validation States.
This preserves the evolution of validation knowledge rather than
presenting only the latest conclusion.
Determination Is Not Validation State
This boundary is fundamental.Validation Determination answers:
What does this governed validation event demonstrate?
Validation State answers:
What formal validation condition does the Validation Object
currently hold after considering the applicable determination,
validity conditions, lifecycle status, and change?
The eighth and ninth Parent Standards must therefore
remain separate.
Governance Boundary
Validation Determination Standard begins when a sufficientlycomplete and conformant Validation Execution Record is ready
for determination.
It ends when the governed validation record has been interpreted
into criterion-level findings and an overall Validation
Determination with explicit scope, conditions, limitations,
conflicts, uncertainty, and traceability.
VDTS does not determine:
- persistent Validation State,
- Validation State expiration,
- operational reliance authorization,
- reliance transfer,
- revalidation triggers,
- or post-determination lifecycle governance.
These responsibilities belong to subsequent VALIDOS™
Parent Standards.
Minimum Governance Requirements
A conforming implementation of VDTS should establish:- 1. an identifiable Validation Determination Basis,
- 2. determination-ready execution,
- 3. qualified execution results,
- 4. explicit criterion-level determinations,
- 5. treatment of mandatory and critical criteria,
- 6. explicit treatment of non-determinability,
- 7. governed aggregation or cross-criterion interpretation,
- 8. contradiction and conflict handling,
- 9. uncertainty integration,
10. propagation of material evidence, source, and execution
limitations, 11. a bounded determination scope, 12. determination
conditions and restrictions, 13. an overall Validation
Determination, 14. determination traceability, 15. and a persistent
Validation Determination Record.
Governance Outputs
VDTS may produce:- Validation Determination Basis,
- Determination-Ready Result Set,
- Validation Result Qualification Record,
- Criterion Determination Record,
- Criterion Satisfaction Map,
- Criterion Non-Satisfaction Record,
- Conditional Criterion Determination,
- Criterion Not Determinable Record,
- Mandatory Criteria Determination,
- Critical Criteria Determination,
- Determination Conflict Record,
- Validation Uncertainty Record,
- Cross-Criterion Interpretation Record,
- Determination Aggregation Record,
- Partial Determination Record,
- Determination Scope Record,
- Determination Condition Record,
- Validation Determination,
- Validation Determination Record,
- Validation Determination Traceability Map,
- Determination Reassessment Trigger,
- Determination Change Record,
- Determination Suspension Record,
- Determination Withdrawal Record,
- and Determination Continuity Reference.
Operational Applications
Validation Determination Standard may be applied across:- artificial intelligence,
- machine learning,
- autonomous systems,
- AI-generated outputs,
- software systems,
- datasets,
- predictions,
- simulations,
- scientific validation,
- healthcare,
- financial services,
- industrial systems,
- cybersecurity,
- critical infrastructure,
- regulatory environments,
- digital identities,
- operational governance,
- public-sector systems,
- and any governed environment requiring a formal validation conclusion.
Relationship to Other OOF Architectures
Validation Determination Standard interoperates with:- GOA™
- OBIDENITY®
- INTEGROS®
- ORA™
- AGA™
- AIG®
- CLIA®
- MGIA™
- ASGA™
- RIS™
by providing the canonical validation-governance methodology through
which the complete governed validation record is transformed into a
bounded and traceable Validation Determination.
GOA™ may provide relevant determination authority and
governance conditions.
OBIDENITY® may preserve the identity and continuity of the
Validation Object and related records.
INTEGROS® may provide integrity conditions affecting evidence,
records, and determination continuity.
ORA™ may provide operational-reality context relevant
to interpretation.
AGA™ may establish accountability for determination roles
and decisions.
RIS™ may influence the strength of determination required for
high-consequence validation.
Specialized AI, cognition, memory, and autonomous-system
architectures may provide domain-specific criteria and conditions
consumed by VDTS.
VDTS does not replace those architectures.
It governs specifically what the completed validation process can
legitimately conclude.
Validation Determination Standard
Architecture: VALIDOS™ — Validation Governance ArchitectureCategory: AI & Interpretation · Subcategory: Validation Governance
Canonical Definition: Validation Determination Standard (VDTS)
defines the governance conditions under which the complete governed
validation record is evaluated, integrated, interpreted, bounded,
and transformed into a formal Validation Determination establishing
what the executed validation legitimately demonstrates about the
Validation Object relative to the applicable Validation Criteria,
thresholds, conditions, evidence, methodological limitations,
execution conformity, uncertainty, conflicts, and approved
Validation Scope.
Governed Space: Validation Determination
Validation results become a legitimate determination only when the
conclusion remains bounded by what the governed validation record
can actually demonstrate.
→ View Standard
Module Architecture
→ Validation Determination Basis & Result Qualification Module (VDBRQM)
→ Validation Criterion Determination Module (VCDM)
→ Validation Determination Conflict & Uncertainty Governance Module (VDCUGM)
→ Validation Cross-Criterion Integration Module (VCCIM)
→ Overall Validation Determination Module (OVDM)
→ Validation Criterion Determination Module (VCDM)
→ Validation Determination Conflict & Uncertainty Governance Module (VDCUGM)
→ Validation Cross-Criterion Integration Module (VCCIM)
→ Overall Validation Determination Module (OVDM)
Parent Resources
Standards Compatibility
→ Validation Criteria Standard
Operational compatibility within the governed validation lifecycle.
→ Validation Evidence Fitness Standard
Operational compatibility within the governed validation lifecycle.
→ Validation Execution Standard
Operational compatibility within the governed validation lifecycle.
→ Validation State Governance Standard
Operational compatibility within the governed validation lifecycle.
→ Validation Reliance & Revalidation Standard
Operational compatibility within the governed validation lifecycle.
Operational compatibility within the governed validation lifecycle.
→ Validation Evidence Fitness Standard
Operational compatibility within the governed validation lifecycle.
→ Validation Execution Standard
Operational compatibility within the governed validation lifecycle.
→ Validation State Governance Standard
Operational compatibility within the governed validation lifecycle.
→ Validation Reliance & Revalidation Standard
Operational compatibility within the governed validation lifecycle.
Related Documents
→ About Validation Determination Standard
→ VALIDOS™ Validation Governance Architecture — Validation Governance Layer
→ VALIDOS™ Validation Governance Architecture — Validation Governance Layer