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Make every important claim examinable.

A buyer should be able to move from a product statement to the evidence behind it and understand what that evidence does not establish. An investor should be able to distinguish an encouraging development result from a capability a customer can adopt. Quality work connects those questions to the version, intended use and decision under review. Its value is practical: fewer assumptions hidden between a promising idea and the next commitment.

PHARMORIS remains in controlled development. This page sets out a proposed approach to quality and buyer assurance. Internal checks, external reviews and formal certification are separate evidence categories; describing one does not imply that the others have been achieved.

Start with the behaviour the buyer needs

A requirement becomes useful when a reviewer can examine it. For a medicines review workflow, that might mean preserving the source of an assumption, identifying the person who accepted a decision or recording the reason a handover stopped. The evaluation should state who needs that behaviour and what happens if it fails. We would propose agreeing these requirements with the intended users, rather than equating a long feature list with fitness for their setting.

Connect claims to evidence, including the gaps

The proposed artefact is a claim-to-evidence register. It would record the precise claim, intended scope, supporting result, assessed version, limitation and next review decision. A design intention would remain an intention. A demonstration would establish only the behaviour observed in that demonstration. Where a claim has no suitable support, the register would identify the question still to answer instead of filling the space with a broad assurance statement.

Choose examples that resemble the work

A polished example can miss the conditions that make an operational task difficult. A proposed assessment would include incomplete inputs, conflicting assumptions, repeated handovers and requests that should be declined. Reviewers would compare the results with the agreed requirements and a credible existing approach. For an independent pharmacy, checking burden might be a decisive constraint. For a health system, the ability to reconstruct the decision across several roles may matter more than speed alone.

Keep a result attached to what was assessed

A finding needs enough context to be interpreted later: the version, configuration, inputs, method and conditions of assessment. If those change, the team should explain which conclusions remain applicable and which need further work. The proposed register would therefore support a change discussion as well as an initial review. The objective is to make the consequence of a change understandable, without suggesting that every modification requires an identical assessment regardless of its effect.

Use the appropriate assurance route

For an NHS-facing digital health assessment, current DTAC guidance is a relevant starting point alongside other applicable processes. NHS England introduced a revised form in February 2026 and says the previous form should not be used from 6 April 2026. The actual assessment must use the current materials and the intended product scope. Referencing DTAC does not establish that PHARMORIS has completed an assessment, and it does not replace a separate determination of medical-device or other regulatory responsibilities.

Review value without mistaking a forecast for a result

Quality also applies to the commercial case. An expected benefit should show its assumptions, comparator and implementation costs. A later observation should identify what was measured and which alternative explanations remain. An evaluation could find that the workflow is clearer but introduces too much review effort, or that a smaller intervention is sufficient. Recording that result honestly helps the buyer make a better decision and gives development a more useful direction than treating every completed exercise as a success.

Agree a proportionate review

We invite quality, procurement and medicines colleagues to identify one capability they would need to examine before committing further resources. Bring the decision, the evidence your organisation expects and the reviewers who would interpret it. The next step would be a scoped review proposal with deliverables, responsibilities and any fee agreed separately. It should end with a clear decision to continue, narrow the work, obtain further evidence or stop.

Primary assurance references

NHS England's current DTAC guidance explains the framework and current form. NICE's evidence standards framework provides a separate reference for evaluating digital-health evidence. Neither reference is a PHARMORIS approval or endorsement. The claim-to-evidence register is a proposed NEUVIOR review artefact, not a certification scheme.

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