Quality Documentation Manager

What This Skill Does

This skill assists in designing and managing document control systems for ISO 13485-compliant quality management systems. It includes guidance on numbering conventions, approval workflows, and change control. It's useful for quality managers and document control specialists.

When to Use

• Implement document control workflows.
• Design document numbering systems.
• Manage approval and review processes.
• Control document changes.
• Ensure 21 CFR Part 11 compliance.
• Manage the document lifecycle.

Key Features

• Document control workflow from creation to obsolescence.
• Document numbering system guidelines.
• Approval and review process steps.
• Change control process details.21 CFR Part 11 compliance information.
• Document lifecycle stages definition.

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 Numbering System Approval and Review Process Change Control Process 21 CFR Part 11 Compliance Reference Documentation Tools

Document Control Workflow

Implement document control from creation through obsolescence:

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

Document Lifecycle Stages

Document Types and Prefixes

Required Reviewers by Document Type

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

Numbering Workflow

Author requests document number from Document Control Document Control verifies category assignment Document Control assigns next available sequence number Number recorded in Document Master List Author creates document using assigned number Validation: Number format matches standard; no duplicates in Master List

Revision Designation

See references/document-control-procedures.md for complete numbering guidance.

Approval and Review Process

Obtain required reviews and approvals before document release.

Review Workflow

Author completes document draft Author submits for review via routing form or DMS Reviewers assigned based on document type Reviewers provide comments within review period (5-10 business days) Author addresses comments and documents responses Author resubmits revised document Approvers sign and date Validation: All required reviewers completed; all comments addressed with documented disposition

Comment Disposition

Approval Matrix

Document Level 1 (Policy/QM): CEO or delegate + QA Manager Document Level 2 (SOP): Department Manager + QA Manager Document Level 3 (WI/TF): Area Supervisor + QA Representative

Signature Requirements

Change Control Process

Manage document changes systematically through review and approval.

Change Control Workflow

Identify need for document change Complete Change Request Form with justification Document Control assigns change number and logs request Route to reviewers for impact assessment Obtain approvals based on change classification Author implements approved changes Update revision number and change history Validation: Changes match approved scope; change history complete

Change Classification

Impact Assessment Checklist

Change History Documentation

Each document must include change history:

21 CFR Part 11 Compliance

Implement electronic record and signature controls for FDA compliance.

Part 11 Scope