About Validation Criteria Standard
Defining the Conditions Against Which Validity Is Judged
Knowing what is being validated is not enough.
Knowing why it is being validated is not enough.
Knowing what validation must cover is not enough.
Validation also requires an explicit basis for judgment.
Validation Criteria Standard (VCRS) is the third Parent Standard of
VALIDOS™ — Validation Governance Architecture, governing how
validation requirements, criteria, thresholds, acceptance
conditions, rejection conditions, and evaluation boundaries are
established before validation methodology and execution begin.
VCRS addresses one fundamental question:
Against which explicit, justified, and governable conditions should
the Validation Object be evaluated?
Knowing what is being validated is not enough.
Knowing why it is being validated is not enough.
Knowing what validation must cover is not enough.
Validation also requires an explicit basis for judgment.
Validation Criteria Standard (VCRS) is the third Parent Standard of
VALIDOS™ — Validation Governance Architecture, governing how
validation requirements, criteria, thresholds, acceptance
conditions, rejection conditions, and evaluation boundaries are
established before validation methodology and execution begin.
VCRS addresses one fundamental question:
Against which explicit, justified, and governable conditions should
the Validation Object be evaluated?
Why Validation Criteria Standard Exists
A validation process can appear rigorous while its underlyingcriteria remain unclear.
A system may be extensively tested without an explicit definition of
what constitutes acceptable performance.
A model may be evaluated against thresholds selected only after
results are known.
A claim may be assessed according to standards that were never
formally established.
Different evaluators may apply different expectations to the same
Validation Object.
In each case, validation activity exists, but the basis for
determining validity remains unstable.
VCRS prevents this by establishing a governed Validation Criteria
Framework before conclusions are reached.
Criteria Before Method
VALIDOS™ establishes an important methodological sequence:First determine what must be demonstrated.
Then determine how it should be examined.
Validation Criteria therefore precede Validation Method.
A criterion defines the condition against which the Validation
Object will be evaluated.
A method defines how evidence concerning that condition will be
obtained or examined.
These responsibilities must remain separate.
For example:
Criterion: a defined performance threshold must be satisfied.
Method: the statistical, experimental, observational, computational,
documentary, expert, or other procedure used to evaluate whether
that threshold has been satisfied.
Separating criteria from method allows VALIDOS™ to remain
methodologically stable even when validation technologies and
techniques change.
From Validation Mandate to Validation Criteria
VCRS receives the Validation Mandate established through ValidationPurpose & Scope governance.
It transforms:
Purpose + Scope + Depth + Applicability + Limitations
into:
Requirements + Criteria + Thresholds + Acceptance Conditions +
Rejection Conditions
The resulting Validation Criteria Framework becomes the evaluation
reference for subsequent validation activity.
Criteria Must Be Explicit
Implicit expectations create unstable validation.A governed criterion should make it possible to determine what
characteristic is being evaluated and what condition must
be satisfied.
Criteria may originate from:
- operational requirements,
- safety requirements,
- performance requirements,
- integrity requirements,
- regulatory obligations,
- legal requirements,
- contractual requirements,
- scientific knowledge,
- technical specifications,
- domain standards,
- governance requirements,
- risk conditions,
- or other legitimate validation references.
VCRS does not assume that every available requirement automatically
becomes a validation criterion.
Its relevance to the approved Validation Purpose and Scope must
first be established.
Not All Criteria Are Equal
Different criteria may perform different governance functions.Some may be mandatory.
Some may apply only under defined conditions.
Some may provide supporting information.
Some may immediately exclude a particular validation outcome.
Others may depend upon several subordinate criteria.
VCRS therefore allows criteria to be classified according to their
role within the Validation Criteria Framework.
This prevents materially different validation conditions from being
treated as if they carried identical significance.
Thresholds Must Have a Basis
Many validation criteria require a boundary between acceptable andunacceptable conditions.
That boundary may take the form of:
- a minimum value,
- a maximum value,
- a permitted range,
- a tolerance,
- a confidence level,
- an error boundary,
- a categorical state,
- or another defined threshold.
VCRS requires material thresholds to have an identifiable basis.
A threshold should not move merely because the observed result would
otherwise fail.
This creates a fundamental governance protection:
The target should not be rewritten after the result is known.
Acceptance Is Not the Same as Validity
Satisfaction of one validation criterion does not necessarily meanthat the Validation Object is valid.
A complex validation may contain many criteria.
Some may be satisfied.
Some may fail.
Some may remain unresolved.
Some may be conditional.
VCRS governs the criteria against which those results will later
be interpreted.
The final relationship between criterion outcomes and the overall
Validation Determination belongs to subsequent VALIDOS™ governance.
Failure Is Not the Same as Missing Evidence
VALIDOS™ also preserves another important distinction.A criterion may be:
Satisfied
or:
Not Satisfied
But validation may also be unable to determine satisfaction because:
- evidence is unavailable,
- evidence is insufficient,
- execution is incomplete,
- the source is unreliable,
- uncertainty remains unresolved,
- or a required validation activity could not be performed.
These conditions should not automatically be represented as
criterion failure.
VCRS establishes the evaluation condition.
Later VALIDOS™ standards determine whether sufficient validated
information exists to evaluate it.
Criteria Must Match the Validation Mandate
Validation Criteria cannot exist independently of the ValidationPurpose and Scope.
The governing relationship is:
Validation Object → Purpose & Scope → Validation Criteria
If a criterion has no meaningful relationship to the approved
Validation Mandate, its role in the validation process
requires justification.
If a material part of the Validation Mandate has no corresponding
criteria, the validation may be incomplete.
VCRS therefore requires both criteria relevance and
criteria completeness.
Criteria Conflict Must Be Visible
Real validation environments may contain conflicting requirements.Performance may conflict with safety.
Operational efficiency may conflict with robustness.
Different regulatory frameworks may establish different thresholds.
Scientific references may disagree.
Multiple governance requirements may compete.
VCRS does not assume that these conflicts disappear.
It requires them to become explicit governance objects before they
influence validation conclusions.
A validation process should not silently choose whichever criterion
produces the preferred outcome.
Criteria Must Remain Stable
Validation becomes unreliable when its evaluation conditions changeinvisibly during the process.
VCRS therefore treats material criteria changes as
governance events.
Where a criterion or threshold changes, the effect on:
Method → Evidence → Execution → Determination
must be considered.
This also means that a historical Validation Determination must
remain connected to the criteria version under which it
was produced.
Criteria Versioning Matters
A Validation Object may be evaluated today against one ValidationCriteria Framework and later against a revised framework.
The object itself may remain unchanged while the applicable
validation criteria evolve.
VCRS therefore preserves the question:
Which criteria governed this validation determination?
Without this reference, two apparently identical validation results
may represent fundamentally different evaluation conditions.
Criteria Are Not Evidence
A criterion defines what must be established.Evidence provides information relevant to establishing it.
These concepts must remain separate.
For example:
Criterion: system error must remain below an approved threshold.
Evidence: measured system-performance data.
A large quantity of evidence cannot compensate for an
undefined criterion.
Likewise, a perfectly defined criterion cannot produce a reliable
determination without adequate evidence.
VALIDOS™ governs these responsibilities through separate
governance spaces.
Governance Rather Than Technical Testing
VCRS does not prescribe a universal set of criteria for every AIsystem, organization, model, dataset, decision, simulation, or
operational environment.
Different Validation Objects and purposes require different
substantive criteria.
VCRS instead governs how criteria themselves must be established
and controlled.
This allows the standard to remain technology-neutral and
domain-independent while still providing a common validation-
governance methodology.
Position Within VALIDOS™
Validation Criteria Standard is the third Parent Standard ofVALIDOS™ — Validation Governance Architecture.
Its architectural position is:
Validation Object → Validation Purpose & Scope → Validation Criteria
→ Validation Method → Validation Evidence Fitness → Validation
Source Reliability → Validation Execution → Validation Determination
→ Validation State → Validation Reliance & Revalidation
The first Parent Standard asks:
What exactly are we validating?
The second asks:
Why are we validating it, what must validation cover, and within
which limits may it apply?
The third asks:
Against what conditions should validity be judged?
Only after these questions have been answered should VALIDOS™
proceed to:
How should those conditions actually be examined?
Relationship to Other OOF® Architectures
VCRS operates alongside complementary OOF® governance architectures.GOA™ may provide governance requirements, authority conditions, and
structural governance references.
INTEGROS® may provide integrity conditions that become relevant
validation requirements.
ORA™ may provide operational conditions against which validation
criteria must be established.
OBIDENITY® may provide identity, origin, ownership, provenance, and
continuity conditions.
AGA™ may provide accountability and responsibility requirements.
RIS™ may provide risk conditions relevant to validation criteria
and thresholds.
AIG®, CLIA®, MGIA™, and ASGA™ may provide domain-specific governance
requirements that can become validation criteria where relevant.
VCRS does not replace those architectures.
It provides the validation-governance mechanism through which
relevant requirements can become explicit conditions against which a
Validation Object is evaluated.
Why It Matters
Without explicit criteria, validation can become a conclusionsearching for justification.
With governed criteria, it becomes possible to determine:
- what was expected,
- why it was expected,
- which threshold applied,
- what constituted acceptance,
- what constituted rejection,
- which criteria were mandatory,
- which conditions were unresolved,
- which criteria version was used,
- and whether the eventual determination actually followed the established evaluation framework.
This makes validation more explainable, comparable, reproducible,
auditable, and governable.
Foundational Principle
Validity cannot be governed against criteria that were neverexplicitly established.
Parent Resources
Related Documents
→ Validation Criteria Standard
→ VALIDOS™ Validation Governance Architecture — Validation Governance Layer
→ VALIDOS™ Validation Governance Architecture — Validation Governance Layer