The hardware and bandwidth for this mirror is donated by dogado GmbH, the Webhosting and Full Service-Cloud Provider. Check out our Wordpress Tutorial.
If you wish to report a bug, or if you are interested in having us mirror your free-software or open-source project, please feel free to contact us at mirror[@]dogado.de.

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.
Health stats visible at Monitor.