Evidence Health & Readiness Score
Score how ready a control set is from the status of its expected evidence: current, weak, pending review, missing, expired, or superseded. Readiness is a documented, inspectable formula — the weighted sum over the total requirement count — and missing, expired, or superseded evidence contributes zero, so absent data can never round up to compliant. Returns a readiness percentage, a band, and the gap list. A scoping aid, not a validated assurance system.
OUTPUT
TIME
Limitations — read before you rely on this
- This is a scoping aid, not a validated system, and not an evidence-management system of record. Reproduce the rollup against your real requirement-to-evidence mapping; a count-based score is a summary, not the evidence itself.
- It aggregates counts, not the adequacy of individual evidence. "Current" here means you marked it current — whether a given artifact actually demonstrates its control is a judgement the count cannot make for you.
- The weights and bands are SPEQ judgement, not regulatory allowances. A regulator does not accept 90% readiness as compliant; treat the score as a management view of where the gaps are, not a compliance statement.
- It scores a snapshot. Evidence expires and is superseded over time, so readiness decays without maintenance — a score is only true for the moment its statuses were entered.
WHAT THIS CALCULATES
How audit-ready a control set is, from the status of its expected evidence. Each requirement’s evidence is one of current, weak, pending review, missing, expired, or superseded; the tool returns a readiness percentage, a band, and the gap list. The formula is documented and inspectable, and — the rule that matters — missing, expired, and superseded evidence contributes zero, so absent data can never round up to compliant.
THE METHOD
readiness = Σ( count_status × weight_status ) ÷ total; weight: current 1.0, weak 0.5, pending-review 0.25, missing/expired/superseded 0- count_status
- the number of requirements whose expected evidence is in that status
- weight_status
- the credit that status earns toward readiness — full for current, partial for weak/pending, zero for missing/expired/superseded
- total
- the total number of requirements across all statuses — the denominator that stops absent evidence from being ignored
- readiness
- the weighted fraction of requirements with adequate evidence, 0–100%, banded strong (≥90%) / partial (≥60%) / weak
The weights and the band thresholds are SPEQ judgement, stated so they can be inspected — not regulatory constants. What is not judgement: missing, expired, and superseded evidence is weighted zero by rule, because counting absent or stale evidence as compliant is the failure this design exists to prevent. Monotonic: upgrading a requirement’s evidence never lowers readiness.
THE INPUTS, AND WHAT THEY MEAN
- Requirements per evidence status
- For each status, how many of your requirements’ expected evidence currently sits there. The denominator is every requirement you are accountable for — including the ones with no evidence, which is exactly what keeps a gap visible instead of silently excluded.
- Status weights (fixed here)
- The credit each status earns comes from the evidence catalog. Current is full credit; weak and pending-review are partial and flagged; missing, expired, and superseded are zero and can never round up to compliant.
How audit-ready is this control set?
Enter how many requirements’ expected evidence sits in each status. Readiness is a documented formula — the weighted sum over the total requirement count — and missing, expired, and superseded evidence counts as zero, so absent data can never round up to compliant. SPEQ returns a readiness percentage, a band, and the gaps.
- Weak: 2 requirements
- Pending review: 1 requirement
- Missing: 3 requirements
- Expired: 1 requirement
- Superseded: 1 requirement
13.3 of 20 requirements’ worth of adequate evidence → 66% readiness (partial). 5 requirements have missing, expired, or superseded evidence that counts as zero — never as compliant.
HOW TO READ THE OUTPUT
- Readiness is a coverage measure, not a pass mark. 80% readiness means a fifth of your requirements’ evidence is weak or absent — read the gap list, because which requirements are weak matters far more than the headline percentage.
- A high score with expired or superseded evidence is a warning, not a comfort. Stale evidence describes a system that may no longer exist; it earns zero here on purpose, so a drop after marking evidence expired is the tool doing its job.
- Weak and pending-review are partial credit, not full. They keep a requirement from reading as a total gap while signalling the work left — strengthen the weak evidence and get the pending evidence reviewed to convert partial credit to full.
- The denominator is the honest part. Scoring only the requirements that have evidence would flatter you; including the missing ones is what makes the number defensible in front of an auditor.
WORKED EXAMPLE
A control set of 20 requirements: 12 have current evidence, 2 weak, 1 pending review, 3 missing, 1 expired, 1 superseded.
- Current
- 12
- Weak / pending review
- 2 / 1
- Missing / expired / superseded
- 3 / 1 / 1
RESULT
Two-thirds ready, and the number is honest precisely because the five requirements with missing, expired, or superseded evidence sit in the denominator earning nothing. The priority is not the weak or pending items — it is the five zero-credit gaps, because those are the requirements an inspector would find with no defensible evidence at all.
REGULATORY BASIS
- ICH Q10 — Pharmaceutical Quality System
- The quality-system expectation that controls are demonstrably effective and supported by current records — the basis for treating evidence as a first-class object.
- ISPE GAMP 5 (2nd ed.) — A Risk-Based Approach to Compliant GxP Computerized Systems
- The documented-evidence and periodic-review expectations that make expired or superseded evidence a real gap, not a formality.
- 21 CFR Part 211 — cGMP for Finished Pharmaceuticals
- The recordkeeping requirements whose absence is a citation — the reason missing evidence must never count as compliant.