Regulated Quality Systems: FDA QMSR and ISO 13485:2016

---
doc-classify:
  - select: heading[depth="1"]
    role: project
  - select: heading[depth="2"]
    role: case
  - select: heading[depth="3"]
    role: evidence
---

# Infusion Rate Calculator: Design and Development File (illustrative)
@id ddf-example

## DI-014: Rate entry rejects values above the configured maximum
@id TC-DI-014

```yaml META
  requirementID: DI-014        # design input, ISO 13485:2016 §7.3.3
  riskControl: RC-031          # ISO 14971 risk control for hazard H-007
  softwareRequirement: SRS-112 # IEC 62304 §5.2 software requirement
  Priority: High
```

### Evidence
@id TC-DI-014

```yaml META
  cycle: 2.0
  cycle-date: 2026-10-12
  assignee: Verification engineer
  status: passed
```

- [Verification record](./evidence/TC-DI-014/2.0/result.auto.json)

# Parse the records and evidence into resource-surveillance.sqlite.db
spry rb run qualityfolio.md

# Serve the dashboard on this machine only
surveilr web-ui -d ./resource-surveillance.sqlite.db --port 9227 --host localhost

-- Synthetic illustration: design inputs traced to risk controls and
-- verification, ISO 13485:2016 §7.3. Each table stands in for records in your
-- design and development file.
CREATE TABLE IF NOT EXISTS design_input (input_id TEXT PRIMARY KEY, title TEXT NOT NULL);
CREATE TABLE IF NOT EXISTS risk_control (control_id TEXT PRIMARY KEY, hazard_id TEXT NOT NULL, input_id TEXT REFERENCES design_input (input_id));
CREATE TABLE IF NOT EXISTS verification (
  record_id TEXT PRIMARY KEY,
  input_id  TEXT NOT NULL REFERENCES design_input (input_id),
  status    TEXT CHECK (status IN ('passed', 'failed', 'blocked')),
  run_date  TEXT
);

SELECT d.input_id,
       d.title,
       group_concat(DISTINCT r.control_id)             AS risk_controls,
       COUNT(DISTINCT v.record_id)                     AS verification_records,
       COALESCE(MAX(v.run_date), '-')                  AS last_run,
       CASE
         WHEN COUNT(v.record_id) = 0 THEN 'not verified'
         WHEN SUM(v.status = 'passed') = 0 THEN 'no passing record'
         ELSE 'verified'
       END                                             AS trace_status
FROM design_input d
LEFT JOIN risk_control r ON r.input_id = d.input_id
LEFT JOIN verification v ON v.input_id = d.input_id
GROUP BY d.input_id, d.title
ORDER BY CASE trace_status WHEN 'not verified' THEN 1 WHEN 'no passing record' THEN 2 ELSE 3 END, d.input_id;

-- Synthetic illustration: label records missing an element 21 CFR 820.45
-- asks to be checked (UDI, expiration date, storage, handling and processing
-- instructions). label_record stands in for your labeling records.
CREATE TABLE IF NOT EXISTS label_record (
  label_id   TEXT PRIMARY KEY,
  device     TEXT NOT NULL,
  udi        TEXT,
  expiration TEXT,
  storage    TEXT,
  handling   TEXT,
  processing TEXT
);

SELECT label_id,
       device,
       trim(
         CASE WHEN udi        IS NULL OR udi        = '' THEN 'UDI '        ELSE '' END ||
         CASE WHEN expiration IS NULL OR expiration = '' THEN 'expiration ' ELSE '' END ||
         CASE WHEN storage    IS NULL OR storage    = '' THEN 'storage '    ELSE '' END ||
         CASE WHEN handling   IS NULL OR handling   = '' THEN 'handling '   ELSE '' END ||
         CASE WHEN processing IS NULL OR processing = '' THEN 'processing ' ELSE '' END
       ) AS missing
FROM label_record
WHERE missing <> ''
ORDER BY device, label_id;