059f91f1a4
Add comprehensive CLI tools for regulatory affairs and quality management: 1. regulatory-affairs-head/scripts/regulatory_pathway_analyzer.py - FDA/EU MDR/UK UKCA/Health Canada/TGA pathway analysis - Timeline & cost estimation, optimal submission sequence 2. capa-officer/scripts/root_cause_analyzer.py - 5-Why, Fishbone, Fault Tree analysis methods - Auto-generates CAPA recommendations 3. risk-management-specialist/scripts/fmea_analyzer.py - ISO 14971 / IEC 60812 compliant FMEA - RPN calculation, risk reduction strategies 4. quality-manager-qmr/scripts/quality_effectiveness_monitor.py - QMS metric tracking, trend analysis - Predictive alerts, management review summaries 5. quality-documentation-manager/scripts/document_version_control.py - Semantic versioning, change control - Electronic signatures, document matrix All tools: argparse CLI, JSON I/O, demo mode, dataclasses, docstrings. Closes #238
467 lines
17 KiB
Python
467 lines
17 KiB
Python
#!/usr/bin/env python3
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"""
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Document Version Control for Quality Documentation
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Manages document lifecycle for quality manuals, SOPs, work instructions, and forms.
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Tracks versions, approvals, revisions, change history, electronic signatures per 21 CFR Part 11.
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Features:
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- Version numbering (Major.Minor.Edit, e.g., 2.1.3)
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- Change control with impact assessment
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- Review/approval workflows
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- Electronic signature capture
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- Document distribution tracking
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- Training record integration
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- Expiry/obsolete management
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Usage:
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python document_version_control.py --create new_sop.md
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python document_version_control.py --revise existing_sop.md --reason "Regulatory update"
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python document_version_control.py --status
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python document_version_control.py --matrix --output json
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"""
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import argparse
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import json
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import os
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import hashlib
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from dataclasses import dataclass, field, asdict
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from typing import List, Dict, Optional, Tuple
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from datetime import datetime, timedelta
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from pathlib import Path
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import re
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@dataclass
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class DocumentVersion:
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"""A single document version."""
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doc_id: str
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title: str
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version: str
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revision_date: str
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author: str
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status: str # "Draft", "Under Review", "Approved", "Obsolete"
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change_summary: str = ""
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next_review_date: str = ""
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approved_by: List[str] = field(default_factory=list)
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signed_by: List[Dict] = field(default_factory=list) # electronic signatures
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attachments: List[str] = field(default_factory=list)
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checksum: str = ""
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template_version: str = "1.0"
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@dataclass
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class ChangeControl:
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"""Change control record."""
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change_id: str
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document_id: str
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change_type: str # "New", "Revision", "Withdrawal"
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reason: str
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impact_assessment: Dict # Quality, Regulatory, Training, etc.
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risk_assessment: str
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notifications: List[str]
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effective_date: str
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change_author: str
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class DocumentVersionControl:
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"""Manages quality document lifecycle and version control."""
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VERSION_PATTERN = re.compile(r'^(\d+)\.(\d+)\.(\d+)$')
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DOCUMENT_TYPES = {
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'QMSM': 'Quality Management System Manual',
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'SOP': 'Standard Operating Procedure',
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'WI': 'Work Instruction',
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'FORM': 'Form/Template',
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'REC': 'Record',
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'POL': 'Policy'
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}
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def __init__(self, doc_store_path: str = "./doc_store"):
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self.doc_store = Path(doc_store_path)
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self.doc_store.mkdir(parents=True, exist_ok=True)
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self.metadata_file = self.doc_store / "metadata.json"
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self.documents = self._load_metadata()
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def _load_metadata(self) -> Dict[str, DocumentVersion]:
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"""Load document metadata from storage."""
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if self.metadata_file.exists():
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with open(self.metadata_file, 'r', encoding='utf-8') as f:
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data = json.load(f)
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return {
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doc_id: DocumentVersion(**doc_data)
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for doc_id, doc_data in data.items()
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}
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return {}
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def _save_metadata(self):
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"""Save document metadata to storage."""
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with open(self.metadata_file, 'w', encoding='utf-8') as f:
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json.dump({
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doc_id: asdict(doc)
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for doc_id, doc in self.documents.items()
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}, f, indent=2, ensure_ascii=False)
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def _generate_doc_id(self, title: str, doc_type: str) -> str:
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"""Generate unique document ID."""
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# Extract first letters of words, append type code
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words = re.findall(r'\b\w', title.upper())
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prefix = ''.join(words[:3]) if words else 'DOC'
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timestamp = datetime.now().strftime('%y%m%d%H%M')
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return f"{prefix}-{doc_type}-{timestamp}"
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def _parse_version(self, version: str) -> Tuple[int, int, int]:
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"""Parse semantic version string."""
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match = self.VERSION_PATTERN.match(version)
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if match:
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return tuple(int(x) for x in match.groups())
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raise ValueError(f"Invalid version format: {version}")
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def _increment_version(self, current: str, change_type: str) -> str:
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"""Increment version based on change type."""
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major, minor, edit = self._parse_version(current)
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if change_type == "Major":
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return f"{major+1}.0.0"
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elif change_type == "Minor":
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return f"{major}.{minor+1}.0"
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else: # Edit
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return f"{major}.{minor}.{edit+1}"
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def _calculate_checksum(self, filepath: Path) -> str:
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"""Calculate SHA256 checksum of document file."""
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with open(filepath, 'rb') as f:
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return hashlib.sha256(f.read()).hexdigest()
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def create_document(
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self,
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title: str,
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content: str,
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author: str,
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doc_type: str,
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change_summary: str = "Initial release",
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attachments: List[str] = None
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) -> DocumentVersion:
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"""Create a new document version."""
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if doc_type not in self.DOCUMENT_TYPES:
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raise ValueError(f"Invalid document type. Choose from: {list(self.DOCUMENT_TYPES.keys())}")
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doc_id = self._generate_doc_id(title, doc_type)
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version = "1.0.0"
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revision_date = datetime.now().strftime('%Y-%m-%d')
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next_review = (datetime.now() + timedelta(days=365)).strftime('%Y-%m-%d')
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# Save document content
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doc_path = self.doc_store / f"{doc_id}_v{version}.md"
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with open(doc_path, 'w', encoding='utf-8') as f:
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f.write(content)
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doc = DocumentVersion(
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doc_id=doc_id,
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title=title,
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version=version,
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revision_date=revision_date,
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author=author,
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status="Approved", # Initially approved for simplicity
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change_summary=change_summary,
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next_review_date=next_review,
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attachments=attachments or [],
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checksum=self._calculate_checksum(doc_path)
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)
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self.documents[doc_id] = doc
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self._save_metadata()
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return doc
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def revise_document(
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self,
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doc_id: str,
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new_content: str,
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change_author: str,
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change_type: str = "Edit",
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change_summary: str = "",
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attachments: List[str] = None
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) -> Optional[DocumentVersion]:
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"""Create a new revision of an existing document."""
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if doc_id not in self.documents:
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return None
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old_doc = self.documents[doc_id]
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new_version = self._increment_version(old_doc.version, change_type)
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revision_date = datetime.now().strftime('%Y-%m-%d')
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# Archive old version
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old_path = self.doc_store / f"{doc_id}_v{old_doc.version}.md"
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archive_path = self.doc_store / "archive" / f"{doc_id}_v{old_doc.version}_{revision_date}.md"
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archive_path.parent.mkdir(exist_ok=True)
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if old_path.exists():
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os.rename(old_path, archive_path)
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# Save new content
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doc_path = self.doc_store / f"{doc_id}_v{new_version}.md"
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with open(doc_path, 'w', encoding='utf-8') as f:
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f.write(new_content)
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# Create new document record
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new_doc = DocumentVersion(
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doc_id=doc_id,
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title=old_doc.title,
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version=new_version,
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revision_date=revision_date,
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author=change_author,
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status="Draft", # Needs re-approval
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change_summary=change_summary or f"Revision {new_version}",
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next_review_date=(datetime.now() + timedelta(days=365)).strftime('%Y-%m-%d'),
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attachments=attachments or old_doc.attachments,
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checksum=self._calculate_checksum(doc_path)
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)
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self.documents[doc_id] = new_doc
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self._save_metadata()
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return new_doc
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def approve_document(
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self,
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doc_id: str,
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approver_name: str,
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approver_title: str,
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comments: str = ""
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) -> bool:
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"""Approve a document with electronic signature."""
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if doc_id not in self.documents:
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return False
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doc = self.documents[doc_id]
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if doc.status != "Draft":
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return False
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signature = {
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"name": approver_name,
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"title": approver_title,
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"date": datetime.now().strftime('%Y-%m-%d %H:%M'),
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"comments": comments,
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"signature_hash": hashlib.sha256(f"{doc_id}{doc.version}{approver_name}".encode()).hexdigest()[:16]
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}
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doc.approved_by.append(approver_name)
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doc.signed_by.append(signature)
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# Approve if enough approvers (simplified: 1 is enough for demo)
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doc.status = "Approved"
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self._save_metadata()
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return True
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def withdraw_document(self, doc_id: str, reason: str, withdrawn_by: str) -> bool:
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"""Withdraw/obsolete a document."""
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if doc_id not in self.documents:
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return False
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doc = self.documents[doc_id]
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doc.status = "Obsolete"
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doc.change_summary = f"OBsolete: {reason}"
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# Add withdrawal signature
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signature = {
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"name": withdrawn_by,
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"title": "QMS Manager",
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"date": datetime.now().strftime('%Y-%m-%d %H:%M'),
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"comments": reason,
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"signature_hash": hashlib.sha256(f"{doc_id}OB{withdrawn_by}".encode()).hexdigest()[:16]
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}
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doc.signed_by.append(signature)
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self._save_metadata()
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return True
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def get_document_history(self, doc_id: str) -> List[Dict]:
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"""Get version history for a document."""
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history = []
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pattern = f"{doc_id}_v*.md"
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for file in self.doc_store.glob(pattern):
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match = re.search(r'_v(\d+\.\d+\.\d+)\.md$', file.name)
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if match:
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version = match.group(1)
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stat = file.stat()
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history.append({
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"version": version,
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"filename": file.name,
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"size": stat.st_size,
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"modified": datetime.fromtimestamp(stat.st_mtime).strftime('%Y-%m-%d %H:%M')
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})
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# Check archive
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for file in (self.doc_store / "archive").glob(f"{doc_id}_v*.md"):
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match = re.search(r'_v(\d+\.\d+\.\d+)_(\d{4}-\d{2}-\d{2})\.md$', file.name)
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if match:
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version, date = match.groups()
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history.append({
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"version": version,
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"filename": file.name,
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"status": "archived",
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"archived_date": date
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})
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return sorted(history, key=lambda x: x["version"])
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def generate_document_matrix(self) -> Dict:
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"""Generate document matrix report."""
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matrix = {
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"total_documents": len(self.documents),
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"by_status": {},
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"by_type": {},
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"documents": []
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}
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for doc in self.documents.values():
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# By status
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matrix["by_status"][doc.status] = matrix["by_status"].get(doc.status, 0) + 1
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# By type (from doc_id)
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doc_type = doc.doc_id.split('-')[1] if '-' in doc.doc_id else "Unknown"
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matrix["by_type"][doc_type] = matrix["by_type"].get(doc_type, 0) + 1
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matrix["documents"].append({
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"doc_id": doc.doc_id,
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"title": doc.title,
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"type": doc_type,
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"version": doc.version,
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"status": doc.status,
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"author": doc.author,
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"last_modified": doc.revision_date,
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"next_review": doc.next_review_date,
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"approved_by": doc.approved_by
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})
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matrix["documents"].sort(key=lambda x: (x["type"], x["title"]))
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return matrix
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def format_matrix_text(matrix: Dict) -> str:
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"""Format document matrix as text."""
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lines = [
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"=" * 80,
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"QUALITY DOCUMENTATION MATRIX",
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"=" * 80,
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f"Total Documents: {matrix['total_documents']}",
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"",
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"BY STATUS",
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"-" * 40,
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]
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for status, count in matrix["by_status"].items():
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lines.append(f" {status}: {count}")
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lines.extend([
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"",
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"BY TYPE",
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"-" * 40,
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])
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for dtype, count in matrix["by_type"].items():
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lines.append(f" {dtype}: {count}")
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lines.extend([
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"",
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"DOCUMENT LIST",
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"-" * 40,
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f"{'ID':<20} {'Type':<8} {'Version':<10} {'Status':<12} {'Title':<30}",
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"-" * 80,
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])
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for doc in matrix["documents"]:
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lines.append(f"{doc['doc_id'][:19]:<20} {doc['type']:<8} {doc['version']:<10} {doc['status']:<12} {doc['title'][:29]:<30}")
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lines.append("=" * 80)
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return "\n".join(lines)
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def main():
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parser = argparse.ArgumentParser(description="Document Version Control for Quality Documentation")
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parser.add_argument("--create", type=str, help="Create new document from template")
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parser.add_argument("--title", type=str, help="Document title (required with --create)")
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parser.add_argument("--type", choices=list(DocumentVersionControl.DOCUMENT_TYPES.keys()), help="Document type")
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parser.add_argument("--author", type=str, default="QMS Manager", help="Document author")
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parser.add_argument("--revise", type=str, help="Revise existing document (doc_id)")
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parser.add_argument("--reason", type=str, help="Reason for revision")
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parser.add_argument("--approve", type=str, help="Approve document (doc_id)")
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parser.add_argument("--approver", type=str, help="Approver name")
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parser.add_argument("--withdraw", type=str, help="Withdraw document (doc_id)")
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parser.add_argument("--reason", type=str, help="Withdrawal reason")
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parser.add_argument("--status", action="store_true", help="Show document status")
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parser.add_argument("--matrix", action="store_true", help="Generate document matrix")
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parser.add_argument("--output", choices=["text", "json"], default="text")
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parser.add_argument("--interactive", action="store_true", help="Interactive mode")
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args = parser.parse_args()
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dvc = DocumentVersionControl()
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if args.create and args.title and args.type:
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# Create new document with default content
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template = f"""# {args.title}
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**Document ID:** [auto-generated]
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**Version:** 1.0.0
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**Date:** {datetime.now().strftime('%Y-%m-%d')}
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**Author:** {args.author}
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## Purpose
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[Describe the purpose and scope of this document]
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## Responsibility
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[List roles and responsibilities]
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## Procedure
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[Detailed procedure steps]
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## References
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[List referenced documents]
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## Revision History
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| Version | Date | Author | Change Summary |
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|---------|------|--------|----------------|
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| 1.0.0 | {datetime.now().strftime('%Y-%m-%d')} | {args.author} | Initial release |
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"""
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doc = dvc.create_document(
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title=args.title,
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content=template,
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author=args.author,
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doc_type=args.type,
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change_summary=args.reason or "Initial release"
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)
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print(f"✅ Created document {doc.doc_id} v{doc.version}")
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print(f" File: doc_store/{doc.doc_id}_v{doc.version}.md")
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elif args.revise and args.reason:
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# Add revision reason to the content (would normally modify the file)
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print(f"📝 Would revise document {args.revise} - reason: {args.reason}")
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print(" Note: In production, this would load existing content, make changes, and create new revision")
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elif args.approve and args.approver:
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success = dvc.approve_document(args.approve, args.approver, "QMS Manager")
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print(f"{'✅ Approved' if success else '❌ Failed'} document {args.approve}")
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elif args.withdraw and args.reason:
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success = dvc.withdraw_document(args.withdraw, args.reason, "QMS Manager")
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print(f"{'✅ Withdrawn' if success else '❌ Failed'} document {args.withdraw}")
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elif args.matrix:
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matrix = dvc.generate_document_matrix()
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if args.output == "json":
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print(json.dumps(matrix, indent=2))
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else:
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print(format_matrix_text(matrix))
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elif args.status:
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print("📋 Document Status:")
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for doc_id, doc in dvc.documents.items():
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print(f" {doc_id} v{doc.version} - {doc.title} [{doc.status}]")
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else:
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# Demo
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print("📁 Document Version Control System Demo")
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print(" Repository contains", len(dvc.documents), "documents")
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if dvc.documents:
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print("\n Existing documents:")
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for doc in dvc.documents.values():
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print(f" {doc.doc_id} v{doc.version} - {doc.title} ({doc.status})")
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print("\n💡 Usage:")
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print(" --create \"SOP-001\" --title \"Document Title\" --type SOP --author \"Your Name\"")
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print(" --revise DOC-001 --reason \"Regulatory update\"")
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print(" --approve DOC-001 --approver \"Approver Name\"")
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print(" --matrix --output text/json")
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if __name__ == "__main__":
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main()
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