Submission Readiness Quick Scan
Mark what exists across the eight dimensions an assessor opens early. Returns weighted coverage and an order of work — the heaviest unblocked gap first, and the dimensions whose prerequisites are still unsettled so evidence gathered now would likely be redone. There is no readiness verdict here on purpose.
OUTPUT
TIME
Limitations — read before you rely on this
- This scan makes no determination. It does not say whether a submission is ready, which regulatory framework applies, or what a submission must contain — that determination belongs to the sponsor, against a specific framework.
- SPEQ is not a validated system. Reproduce this scan in your own quality system, where it can be maintained against real evidence rather than against self-declared states.
- The eight dimensions are general to regulated product development. A specific submission type names contents this scan does not, and its own order of assessment.
- The weights are SPEQ judgement, not a regulatory ranking, and every status is self-declared — so the coverage figure carries no weight with any authority.
WHAT THIS CALCULATES
Weighted coverage across the eight dimensions an assessor opens early, the heaviest gap that nothing else is blocking, and which incomplete dimensions rest on prerequisites still unsettled — so evidence gathered there would likely be redone.
THE METHOD
C = Σ(w × s) / Σ(w), where s = 1 complete, 0.5 partial, 0 nothing- C
- Weighted coverage across applicable dimensions, from zero to one. A coverage figure, never a readiness determination.
- Σ
- Summation across the dimensions not marked not applicable. Excluded dimensions leave the denominator as well as the numerator.
- w
- SPEQ weighting for a dimension, higher where its absence undermines the dimensions that depend on it.
- s
- The state score for a dimension: complete, partial or nothing.
Separately, each dimension declares what must be settled before work on it is durable. An incomplete dimension whose prerequisites are unsettled is reported as work that would be redone rather than as the next gap to close.
THE INPUTS, AND WHAT THEY MEAN
- State of each of the eight dimensions
- Complete, partial, nothing, or not applicable, across intended use, risk management, design and development, verification evidence, manufacturing control, quality system, labelling and postmarket surveillance. Not applicable is reported back rather than dropped, so the exclusion stays visible as a decision someone made.
Which gap should you close first?
Mark what exists across the dimensions an assessor opens early. SPEQ returns coverage and an order of work — never a verdict. There is no “ready” band here on purpose: readiness is a determination made by the sponsor against a specific framework, and it is exactly the determination a founder would most like a web form to make for them.
Work here rests on something still unsettled. Evidence gathered against a claim that later changes is only evidence for the claim it was gathered against.
Risk management file
Waiting on Intended use and claims.
Design and development records
Waiting on Intended use and claims.
Verification and performance evidence
Waiting on Intended use and claims, Design and development records.
Manufacturing and supply control
Waiting on Design and development records.
Labelling and instructions
Waiting on Intended use and claims, Verification and performance evidence.
Postmarket surveillance and complaint handling
Waiting on Quality system in operation.
HOW TO READ THE OUTPUT
- There is no readiness band here on purpose. Whether a submission is ready is a determination made by the sponsor against a specific framework for a specific claim, and it is precisely the determination a founder would most like a form to make for them.
- Read "start here" before the coverage figure. It names the heaviest gap nothing else is blocking, which is where work compounds rather than gets repeated.
- A dimension listed as likely to be redone is not a gap to close today. Verification evidence gathered against a claim that later moves is evidence for the claim it was gathered against, and the work is spent twice.
- Coverage can be high while a programme is unready, because this scan knows nothing about the product, the claim or the framework — only whether the things an assessor opens early exist at all.
WORKED EXAMPLE
A company preparing its first submission has strong verification data and an intended-use statement that is still being argued about internally.
- Intended use and claims
- Partial
- Verification and performance evidence
- Complete
- Design and development records
- Partial
- Quality system in operation
- Nothing yet
RESULT
The completed verification is the weakest position on the page, not the strongest. It was generated against a claim that has not been fixed, so if the claim moves the data does not follow it — which is why the scan sends the team back to the statement everyone assumed was settled.
REGULATORY BASIS
- ICH Q10
- Frames the quality system as operating across the lifecycle, which is the basis for scoring a system in use rather than a set of procedures written for a reader.
- ISO 13485:2016
- Requires design and development records that trace requirements through design to verification, which is the traceability the design and verification dimensions are scored against.
- ISO 14971:2019
- Establishes risk management as a lifecycle process feeding design decisions, which is why the risk dimension asks whether the file drove anything rather than whether it exists.