auditing-part11-trails

Generates and verifies 21 CFR Part 11-style audit trails — who/what/when, electronic signatures, and tamper-evidence — for OpenMed pipelines in GxP and clinical-trial (GCP) settings. Use when the user runs OpenMed in a regulated/validated environment and needs an attributable, time-stamped, tamper-evident record of each processing action, electronic-signature manifestations, or computer-system-validation (CSV) evidence. Trigger keywords: 21 CFR Part 11, Part 11, audit trail, electronic signature, e-signature, GxP, GCP, GLP, GMP, CSV, computer system validation, data integrity, ALCOA, tamper-evident, contemporaneous. Pairs adjacent to OpenMed: maps directly onto OpenMed deidentify(audit=True) -> signed AuditReport with .sign(key)/.verify(key), whose repro_hash + HMAC give the tamper-evidence and attribution Part 11 expects. This is a compliance-enablement aid, not a validation certification.

Quality

91%

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Securityby

Passed

No findings from the security scan

Quality

Content

82%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

A strong, well-structured compliance skill: executable quick start, a Part 11-to-OpenMed mapping table, a sequenced workflow with a verification checkpoint, and a candid edge-cases section that resists over-claiming. Minor gains are available in tightening the regulatory preamble and detailing recovery on verification failure.

Suggestions

Trim the introductory regulatory background (the Part 11 attribute list and ALCOA+ expansion) to a one-line pointer, since the mapping table already conveys the specifics.

Expand the verify-failure feedback loop: state explicitly what to do when .verify() returns False (e.g., quarantine the trail, alert QA, do not re-sign over the suspect record).

Consider moving the 'Standards & references' link list into a short references file so the SKILL.md body stays a focused overview, which would also exercise one-level-deep progressive disclosure.

Dimension	Reasoning	Score
Conciseness	The body is mostly efficient — a dense Part 11→OpenMed mapping table and a lean, executable quick start — but the opening regulatory background ('any electronic record used to support a regulatory decision must meet 21 CFR Part 11...') and ALCOA+ expansion could be trimmed slightly without losing actionability.	4 / 5
Actionability	The Quick start is copy-paste ready code covering produce/sign/envelope/verify, the Workflow gives concrete numbered steps, and the mapping table ties each Part 11 expectation to a specific OpenMed mechanism, fully covering the common cases.	5 / 5
Workflow Clarity	The 7-step Workflow is clearly sequenced with an explicit verification checkpoint (step 6, .verify()), so the destructive/batch cap does not bind; however the error-recovery loop beyond the assert on verify failure is only lightly sketched rather than fully spelled out.	4 / 5
Progressive Disclosure	The single ~135-line SKILL.md is well sectioned (When to use, mapping table, Quick start, Workflow, Edge cases, References) with no inlined content that clearly belongs in a separate file; as a self-contained skill it is well organized, though it demonstrates no multi-file progression.	4 / 5
	Total	17 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

An excellent description: third-person voice, explicit 'Use when' trigger guidance, a comprehensive keyword list, and a clearly bounded niche. It also honestly scopes the skill as a compliance-enablement aid rather than a certification.

Dimension	Reasoning	Score
Specificity	Names multiple concrete actions — 'Generates and verifies... audit trails', 'electronic signatures', 'tamper-evidence', and maps onto deidentify(audit=True) with .sign()/.verify() and repro_hash + HMAC — giving comprehensive coverage of the skill's capabilities.	5 / 5
Completeness	It explicitly answers 'what' ('Generates and verifies 21 CFR Part 11-style audit trails') and 'when' ('Use when the user runs OpenMed in a regulated/validated environment and needs...') with concrete trigger phrases.	5 / 5
Trigger Term Quality	The explicit 'Trigger keywords' block lists comprehensive natural terms and synonyms — '21 CFR Part 11', 'audit trail', 'electronic signature', 'e-signature', 'GxP', 'GCP', 'GLP', 'GMP', 'CSV', 'ALCOA', 'tamper-evident', 'contemporaneous'.	5 / 5
Distinctiveness Conflict Risk	It carves a clear niche (Part 11 audit trails for OpenMed pipelines) with distinct triggers that do not overlap with adjacent compliance skills like HIPAA or safe-harbor checking.	5 / 5
	Total	20 / 20 Passed

Validation

100%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 16 / 16 Passed

Validation for skill structure

No warnings or errors.

Repository: maziyarpanahi/openmed
Path: skills/auditing-part11-trails/SKILL.md
Commit: 80da98c

Reviewed: 1 day ago

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