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regulog (development version)

regulog 0.2.1

CRAN resubmission fixes

• Removed “for R” from the package description
• Package names now in single quotes in DESCRIPTION ('shiny', 'SHA-256')
• Shiny examples wrapped in if(interactive()){} per CRAN policy

regulog 0.2.0

New functions

• log_note() — log a free-text annotation or analytical decision as a tamper-evident NOTE entry. Mandatory-reason enforced and included in the hash chain.
• log_signature() — apply an electronic signature per 21 CFR Part 11 §11.100/§11.200. Signer identity is resolved from the session user; entries covered is captured automatically.
• filter_log() — query log entries as a data.frame by type, user, action, or date range. Works directly on .rlog file paths without an active session.
• as.data.frame.regulog() — S3 method to convert a regulog object to a flat data frame, one row per entry (genesis record excluded).
• rl_read() — explicit, logged read of any data source. Records the reader function, resolved file path, row count, and column count as a data_read ACTION entry. Path is resolved by argument name (file, path, data_file, input), falling back to the first unnamed argument — correct even when arguments are supplied out of position.
• with_log() — scoped logging for a code block. Provides a local read() binding tied to the supplied log. Each call is isolated via lexical scope — concurrent calls across Shiny sessions never interfere, and errors inside the block propagate normally without corrupting previously logged entries.

Validation

• IQ/OQ/PQ qualification scripts updated to v0.2:
  • OQ-015 to OQ-024c: tests for log_note(), log_signature(), filter_log(), as.data.frame.regulog(), rl_read(), and with_log(), including concurrent-session isolation
  • PQ-006: annotated clinical analysis workflow with notes and signature
  • PQ-007: regulatory inspector query workflow using filter_log()
• RTM extended with rows covering 21 CFR Part 11 §11.100/§11.200, annotation trail, data read logging, and audit trail query interface.

Documentation

• Package-level documentation with complete workflow, entry type reference, and regulatory coverage table.
• Three vignettes: getting-started, hash-chain, shiny-integration.

regulog 0.1.0

• Initial release.
• regulog_init(), log_action(), log_change() — core audit logging.
• verify_log() — SHA-256 hash chain verification.
• export_audit_trail() — CSV and JSON export with optional signing.
• regulog_shiny_init(), regulog_observer() — Shiny integration.
• IQ/OQ/PQ validation suite (IQ-001–009, OQ-001–014, PQ-001–005).

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.