quality-documentation-manager

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.

1.17x

Quality

73%

Does it follow best practices?

Impact

94%

1.17x

Average score across 6 eval scenarios

Securityby

Passed

No known issues

Optimize this skill with Tessl

npx tessl skill review --optimize ./ra-qm-team/quality-documentation-manager/SKILL.md

Evaluation results

96%

37%

QMS Document Control Setup for New Medical Device Startup

Document numbering and master list

Criteria

Without context

With context

Numbering format

25%

100%

Valid prefixes only

100%

Correct category codes

100%

Sequence format

100%

Document Number field

100%

Title field

100%

Current Revision field

100%

Effective Date field

100%

Status field

100%

Process Owner field

100%

Review Date field

100%

Category field

100%

Storage Location field

100%

Review frequency applied

100%

Updating a Supplier Qualification SOP After Regulatory Audit

Change control and revision management

Criteria

Without context

With context

Change classification

100%

Major approval path

100%

SOP approval authority

80%

100%

Revision number incremented

100%

Change history revision field

100%

Change history date field

100%

Change history description field

100%

Change history author field

100%

Change history approver field

100%

Impact: training assessment

100%

Impact: regulatory assessment

100%

Impact: related documents

100%

CRF step included

62%

100%

Electronic Document Management System Technical Specification

21 CFR Part 11 system controls specification

Criteria

Without context

With context

Audit trail: secure

100%

Audit trail: computer-generated

100%

Audit trail: time-stamped

100%

Audit trail: original values

100%

Audit trail: who/what/when

100%

E-sig: 2 components minimum

100%

E-sig: unique per person

83%

100%

E-sig manifestation: name

100%

E-sig manifestation: date/time

100%

E-sig manifestation: meaning

100%

E-sig: linked to record

100%

Password: minimum length 8

100%

Password: complexity

100%

Password: history 12

100%

Password: 90-day expiry

100%

Account lockout: 5 attempts / 30 min

100%

Session: 15-min inactivity timeout

100%

99%

40%

Document Review and Approval Procedure

Review and approval workflow

Criteria

Without context

With context

SOP reviewers correct

50%

100%

WI reviewers correct

40%

100%

SPEC reviewers correct

100%

Review period stated

87%

All 4 disposition options

75%

100%

Approval Level 1 correct

40%

100%

Approval Level 2 correct

20%

100%

Approval Level 3 correct

50%

100%

Signature elements complete

100%

Comment response documented

100%

18%

QMS Document Distribution and Access Control Policy

Document distribution and obsolescence control

Criteria

Without context

With context

DMS as primary method

100%

Controlled Print with signature log

100%

UNCONTROLLED watermark

100%

REFERENCE ONLY watermark

100%

All 6 access permission levels

100%

OBSOLETE stamp applied

100%

Controlled prints destroyed

100%

Archive obsolete master

100%

Master List 24-hour update

40%

100%

DRAFT watermark on drafts

100%

No obsolete copies in active areas

66%

100%

71%

-20%

QMS Document Compliance Audit

Document validator tool usage

Criteria

Without context

With context

Script invoked

100%

--doc flag used

100%

--output json flag used

100%

Document JSON has required fields

100%

Correct number format in JSON

100%

change_history field present

100%

Multiple documents validated

100%

Report includes compliance score

100%

Report identifies finding severity

100%

--sample flag used for reference

Repository: alirezarezvani/claude-skills
Commit: a96cc20

Evaluated: 27 days ago
Agent: Claude Code
Model: Claude Sonnet 4.6

Table of Contents

QMS Document Control Setup for New Medical Device Startup Updating a Supplier Qualification SOP After Regulatory Audit Electronic Document Management System Technical Specification Document Review and Approval Procedure QMS Document Distribution and Access Control Policy QMS Document Compliance Audit

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