Apply an electronic signature to the audit trail

Records a SIGNATURE entry capturing the signer identity (from the session user), UTC timestamp, number of prior entries covered, and the stated meaning of the signature. Addresses 21 CFR Part 11 §11.100 / §11.200 requirements:

Usage

log_signature(log, meaning)

Arguments

log: A regulog object returned by regulog_init() or regulog_shiny_init().
meaning: The meaning of the signature — what you are certifying. Cannot be blank. Example: "I certify that this analysis is accurate and complete per SAP version 2.0".

Value

The regulog object, invisibly (pipe-friendly).

Details

Identity — resolved from the session user set in regulog_init()
Date and time — UTC timestamp generated automatically at call time
Meaning — the meaning argument; mandatory, cannot be blank
Coverage — number of prior entries in the session, recorded automatically

The SIGNATURE entry is part of the hash chain: any tampering with entries preceding the signature, or with the signature entry itself, is detectable by verify_log().

Examples

log <- regulog_init(app = "analysis", version = "1.0", user = "jsmith")
log_action(
  log, "run", "primary_analysis.R",
  "Primary ANCOVA model executed per SAP section 6.1"
)
#> regulog: logged action 'run' on 'primary_analysis.R'

log_signature(
  log,
  "I certify that this analysis is accurate and complete per SAP version 2.0"
)
#> regulog: signature applied by 'jsmith' covering 1 entry