quality-documentation-manager

这段内容是审核时保存的快照。外部来源才是完整且最新的版本。

---
name: "quality-documentation-manager"
description: Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.
triggers:
  - document control
  - document numbering
  - version control
  - change control
  - document approval
  - electronic signature
  - 21 CFR Part 11
  - audit trail
  - document lifecycle
  - controlled document
  - document master list
  - record retention
---

# Quality Documentation Manager

Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance.

---

## Table of Contents

- [Document Control Workflow](#document-control-workflow)
- [Document Numbering System](#document-numbering-system)
- [Approval and Review Process](#approval-and-review-process)
- [Change Control Process](#change-control-process)
- [21 CFR Part 11 Compliance](#21-cfr-part-11-compliance)
- [Reference Documentation](#reference-documentation)
- [Tools](#tools)

---

## Document Control Workflow

Implement document control from creation through obsolescence:

1. Assign document number per numbering procedure
2. Create document using controlled template
3. Route for review to required reviewers
4. Address review comments and document responses
5. Obtain required approval signatures
6. Assign effective date and distribute
7. Update Document Master List
8. **Validation:** Document accessible at point of use; obsolete versions removed

### Document Lifecycle Stages

| Stage | Definition | Actions Required |
|-------|------------|------------------|
| Draft | Under creation or revision | Author editing, not for use |
| Review | Circulated for review | Reviewers provide feedback |
| Approved | All signatures obtained | Ready for training/distribution |
| Effective | Training complete, released | Available for use |
| Superseded | Replaced by newer revision | Remove from active use |
| Obsolete | No longer applicable | Archive per retention schedule |

### Document Types and Prefixes

| Prefix | Document Type | Typical Content |
|--------|---------------|-----------------|
| QM | Quality Manual | QMS overview, scope, policy |
| SOP | Standard Operating Procedure | Process-level procedures |
| WI | Work Instruction | Task-level step-by-step |
| TF | Template/Form | Controlled forms |
| SPEC | Specification | Product/process specs |
| PLN | Plan | Quality/project plans |

### Required Reviewers by Document Type

| Document Type | Required Reviewers | Required Approvers |
|---------------|-------------------|-------------------|
| SOP | Process Owner, QA | QA Manager, Process Owner |
| WI | Area Supervisor, QA | Area Manager |
| SPEC | Engineering, QA | Engineering Manager, QA |
| TF | Process Owner | QA |
| Design Documents | Design Team, QA | Design Control Authority |

---

## Document Numbering System

Assign consistent document numbers for identification and retrieval.

### Numbering Format

Standard format: `PREFIX-CATEGORY-SEQUENCE[-REVISION]`

```
Example: SOP-02-001-A

SOP = Document type (Standard Operating Procedure)
02  = Category code (Document Control)
001 = Sequential number
A   = Revision indicator
```

### Category Codes

| Code | Functional Area | Description |
|------|-----------------|-------------|
| 01 | Quality Management | QMS procedures, management review |
| 02 | Document Control | This area |
| 03 | Human Resources | Training, competency |
| 04 | Design & Development | Design control processes |
| 05 | Purchasing | Supplier management |
| 06 | Production | Manufacturing procedures |
| 07 | Quality Control | Inspection, testing |
| 08 | CAPA | Corrective/preventive actions |
| 09 | Risk Management | ISO 14