quality-documentation-manager

# 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.

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## 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)

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## 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| Superseded | Replaced by newer revision | Remove from active use |
| Obsolete | No longer applicable | Archive per retention schedule |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/proc...