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).