log_note() — log a free-text annotation or analytical decision as a tamper-evident NOTE entry. Every entry is 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. Also 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. Calls the supplied reader function and records the result as a data_read ACTION entry, capturing the resolved file path, row count, and column count. The path is resolved by argument name (file, path, data_file, input) where possible, 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, so reads inside the block don’t need to repeat the log argument. Each with_log() call is isolated via lexical scope: concurrent calls (e.g. across Shiny sessions) never interfere with one another, and an error inside the block propagates normally without losing or corrupting entries logged before it.
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
Requirements Traceability Matrix extended with rows covering 21 CFR Part 11 §11.100 (signer identity), §11.200 (signature components), annotation trail, data read logging, and audit trail query interface. See inst/validation/RTM_regulog.md for column definitions and a script to verify the RTM stays in sync with the validation scripts and exported API.
Documentation
regulog-package.R — package-level documentation with complete workflow, entry type reference, and regulatory coverage table.
Three vignettes: getting-started, hash-chain, shiny-integration.
