• SRS-001

  reviewed 1. First-launch database initialisation SRS-001

  On first launch, when no database file exists at the configured application data path, the software shall create the local database, apply the current schema version, and create a default local clinic record that serves as the container for locally-created patient records.

  • SYS-001

    reviewed 1. First-launch readiness for local enrolment SYS-001

    When the device is opened on a workstation that has no pre-existing BioFlow data directory, a default local clinic shall be present and immediately available for the clinician to attach newly-enrolled patient records, without requiring the clinician to first create or configure a clinic record manually.

ARCH-001

reviewed 1. Local persistence subsystem ARCH-001

The local persistence subsystem owns the application's local database — a SQLite file encrypted at rest via SQLCipher, located under the configured AppData path — applies schema migrations via Drift on first open, and exposes a typed API to the application layer for the clinic, patient, and recording domain entities.

• IT-001

  reviewedPassed 1. First-launch DB initialisation IT-001

  Instantiate AppDatabase against a temporary filesystem path at which no database file exists. Trigger the initialisation pathway by performing any query that forces Drift's onCreate migration to run. Inspect the resulting state of the database on disk and of the seeded tables.

• SRS-002

  unreviewed 2. Local database confidentiality at rest SRS-002

  The software shall keep the local database file unreadable to any process that opens it without supplying the database credential, and shall reject database read and write operations when the credential is missing or incorrect.

  • SYS-002

    unreviewed 2. Confidentiality of patient data at rest SYS-002

    The device shall keep clinic, patient, clinical-user, recording, and audit-log data stored on the local workstation confidential against any party gaining access to the workstation's filesystem without the operator's BioFlow credentials.

ARCH-002

unreviewed 2. Local database encryption ARCH-002

The local SQLite database is encrypted on disk via the SQLCipher extension. The encryption key is held by flutter_secure_storage, which on Windows persists it as an entry in a DPAPI-encrypted file (flutter_secure_storage.dat) under the user's local app-data directory. On application bootstrap, the key is retrieved from secure storage and generated-and-persisted on first launch if absent. On every database connection open, the database connection service applies the key as the first statement (PRAGMA key) before any other operation; SQLCipher then transparently encrypts and decrypts SQLite pages.

• IT-002

  unreviewedPassed 2. Database file is encrypted at rest IT-002

  Initialise an AppDatabase against a temporary filesystem path through the production openEncryptedConnection pathway with a known test key. Write a canonical row through the typed clinic API and close the database. Attempt to open the resulting file with the plain sqlite3 driver (no credential supplied) and read any user table. Attempt to open the same file through the production pathway with an incorrect key and read any user table. Then re-open the file through the production pathway with the correct key and read the canonical row.