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

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Document Control Workflow

Implement document control from creation through obsolescence:

1. 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obtained | Ready for training/distribution | | Effective | Training complete, released | Available for use | | Superseded | Replaced by newer revision | Remove from active use | | Obsolete | No longer applicable | Archive per retention schedule |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 |

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Document Numbering System

Assign consistent document numbers for identification and retrieval.

Numbering Format

Standard format: INLINECODE0

CODEBLOCK0

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 14971 processes | | 10 | Regulatory Affairs | Submissions, compliance |

Numbering Workflow

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

Revision Designation

Change Type	Revision Increment	Example
Major revision	Increment number	Rev 01 → Rev 02
Minor revision

Increment sub-revision | Rev 01 → Rev 01.1 | | Administrative | No change or letter suffix | Rev 01 → Rev 01a |

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

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Approval and Review Process

Obtain required reviews and approvals before document release.

Review Workflow

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

Comment Disposition

Disposition	Action Required
Accept	Incorporate comment as written
Accept with modification

Incorporate with changes, document rationale | | Reject | Do not incorporate, document justification | | Defer | Address in future revision, document reason |

Approval Matrix

CODEBLOCK1

Signature Requirements

Element	Requirement
Name	Printed name of signer
Signature

Handwritten or electronic signature | | Date | Date signature applied | | Role | Function/role of signer |

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Change Control Process

Manage document changes systematically through review and approval.

Change Control Workflow

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

Change Classification

Class	Definition	Approval Level	Examples
Administrative	No content impact	Document Control	Typos, formatting
Minor

Limited content change | Process Owner + QA | Clarifications | | Major | Significant content change | Full review cycle | New requirements | | Emergency | Urgent safety/compliance | Expedited + retrospective | Safety issues |

Impact Assessment Checklist

Impact Area	Assessment Questions
Training	Does change require retraining?
Equipment

Does change affect equipment or systems? | | Validation | Does change require revalidation? | | Regulatory | Does change affect regulatory filings? | | Other Documents | Which related documents need updating? | | Records | What records are affected? |

Change History Documentation

Each document must include change history:

CODEBLOCK2

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21 CFR Part 11 Compliance

Implement electronic record and signature controls for FDA compliance.

Part 11 Scope

Applies To	Does Not Apply To
Records required by FDA regulations	Paper records
Records submitted to FDA

Internal non-regulated documents | | Electronic signatures on required records | General email communication |

Electronic Record Controls

1. 1. Validate system for accuracy and reliability
2. Implement secure audit trail for all changes
3. Restrict system access to authorized individuals
4. Generate accurate copies in human-readable format
5. Protect records throughout retention period
6. Validation: Audit trail captures who, what, when for all changes

Audit Trail Requirements

Requirement	Implementation
Secure	Cannot be modified by users
Computer-generated

System creates automatically | | Time-stamped | Date and time of each action | | Original values | Previous values retained | | User identity | Who made each change |

Electronic Signature Requirements

Requirement	Implementation
Unique to individual	Not shared between persons
At least 2 components

User ID + password minimum | | Signature manifestation | Name, date/time, meaning displayed | | Linked to record | Cannot be excised or copied |

Signature Manifestation

Every electronic signature must display:

Element	Example
Printed name	John Smith
Date and time

2024-03-15 14:32:05 EST |
| Meaning | Approved for Release |

System Controls Checklist

Access Controls:

• - [ ] Unique user ID for each person
• [ ] Password complexity enforced
• [ ] Account lockout after failed attempts
• [ ] Session timeout after inactivity

Audit Trail:

• - [ ] All record creation logged
• [ ] All modifications logged with old/new values
• [ ] User identity captured
• [ ] Date/time stamp on all entries

Security:

• - [ ] Role-based access control
• [ ] Encryption for data at rest and in transit
• [ ] Regular backup and tested recovery

See references/21cfr11-compliance-guide.md for detailed compliance requirements.

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Reference Documentation

Document Control Procedures

INLINECODE3 contains:

• - Document numbering system and format
• Document lifecycle stages and transitions
• Review and approval workflow details
• Change control process with classification criteria
• Distribution and access control methods
• Record retention periods and disposal procedures
• Document Master List requirements

21 CFR Part 11 Compliance Guide

INLINECODE4 contains:

• - Part 11 scope and applicability
• Electronic record requirements (§11.10)
• Electronic signature requirements (§11.50, 11.100, 11.200)
• System control specifications
• Validation approach and documentation
• Compliance checklist and gap assessment template
• Common FDA deficiencies and prevention

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Tools

Document Validator

CODEBLOCK3

Validates:

• - Document numbering convention compliance
• Title and status requirements
• Date validation (effective, review due)
• Approval requirements by document type
• Change history completeness
• 21 CFR Part 11 controls (audit trail, signatures)

Sample Document Input

CODEBLOCK4

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Document Control Metrics

Track document control system performance.

Key Performance Indicators

Metric	Target	Calculation
Document cycle time	<30 days	Average days from draft to effective
Review completion rate

>95% | Reviews completed on time / Total reviews | | Change request backlog | <10 | Open change requests at month end | | Overdue review rate | <5% | Documents past review date / Total effective | | Audit finding rate | <2 per audit | Document control findings per internal audit |

Periodic Review Schedule

Document Type	Review Frequency
Policy	Every 3 years
SOP

Every 2 years | | WI | Every 2 years | | Specifications | As needed or with product changes | | Forms/Templates | Every 3 years |

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Regulatory Requirements

ISO 13485:2016 Clause 4.2

Sub-clause	Requirement
4.2.1	Quality management system documentation
4.2.2

Quality manual | | 4.2.3 | Medical device file (technical documentation) | | 4.2.4 | Control of documents | | 4.2.5 | Control of records |

FDA 21 CFR 820

Section	Requirement
820.40	Document controls
820.180

General record requirements | | 820.181 | Device master record | | 820.184 | Device history record | | 820.186 | Quality system record |

Common Audit Findings

Finding	Prevention
Obsolete documents in use	Implement distribution control
Missing approval signatures

Enforce workflow before release | | Incomplete change history | Require history update with each revision | | No periodic review schedule | Establish and enforce review calendar | | Inadequate audit trail | Validate DMS for Part 11 compliance |