animal-facility/README.md

Animal Research Facility Quality Management System

A comprehensive QMS template designed for animal research facilities, vivaria, and laboratory animal care programs supporting biomedical research.

🐭 Designed For

• Academic Vivaria - University and medical center animal facilities
• Pharmaceutical Research - Drug discovery and preclinical testing facilities
• Contract Research Organizations (CROs) - Animal study service providers
• Biotechnology Companies - Research and development animal programs
• Government Research Facilities - NIH, CDC, and agency research programs
• Veterinary Schools - Teaching and research animal programs
• Breeding Colonies - Specialized genetic model production facilities

📋 Regulatory Framework

This template supports compliance with:

• PHS Policy - Public Health Service Policy on Humane Care and Use of Laboratory Animals
• USDA/AWA - Animal Welfare Act and Regulations (9 CFR Parts 1-4)
• AAALAC - Association for Assessment and Accreditation of Laboratory Animal Care International
• IACUC - Institutional Animal Care and Use Committee requirements
• Guide for the Care and Use of Laboratory Animals (8th Edition)
• AVMA Guidelines - Euthanasia and veterinary care standards
• OLAW - Office of Laboratory Animal Welfare requirements
• GLP - Good Laboratory Practice for regulated studies (21 CFR Part 58)
• OSHA - Occupational safety for animal handlers
• CDC/NIH BMBL - Biosafety in Microbiological and Biomedical Laboratories

Repository Structure

├── SOPs/
│   ├── Animal-Care/           # Daily care, feeding, environmental enrichment
│   ├── Veterinary-Services/   # Health monitoring, treatments, euthanasia
│   ├── Colony-Management/     # Breeding, genetics, census tracking
│   ├── Facility-Operations/   # Sanitation, cage wash, environmental controls
│   ├── Safety/                # Zoonosis, allergens, occupational health
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── IACUC-Protocols/       # Protocol submission and amendment forms
│   ├── Health-Records/        # Veterinary treatment and observation logs
│   ├── Census-Tracking/       # Animal inventory and disposition records
│   ├── Environmental/         # Temperature, humidity, light cycle logs
│   ├── Training/              # Competency assessments, certifications
│   └── Incident-Reports/      # Adverse events, protocol deviations
├── Policies/                  # Institutional policies and IACUC guidelines
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

• POL-XXX: Policies
• SOP-AC-XXX: Animal Care SOPs
• SOP-VET-XXX: Veterinary Services SOPs
• SOP-COL-XXX: Colony Management SOPs
• SOP-FAC-XXX: Facility Operations SOPs
• SOP-SAF-XXX: Safety SOPs
• WI-XXX: Work Instructions
• FRM-XXX: Forms and Records
• PRO-XXX: IACUC Protocol Templates

🤖 AI-Powered Assistance

This repository includes AtomicAI, your animal facility QMS assistant. Mention @atomicai in any issue or pull request to:

• Draft species-specific SOPs for animal care and handling
• Create IACUC protocol templates and amendments
• Generate veterinary treatment and monitoring procedures
• Develop environmental enrichment programs
• Create biosafety and occupational health procedures
• Review documents for regulatory compliance

Example Prompts

• "@atomicai create an SOP for rodent health monitoring per the Guide"
• "@atomicai draft a post-operative care procedure for surgical models"
• "@atomicai write an environmental enrichment policy for NHPs"
• "@atomicai create an IACUC annual review checklist"
• "@atomicai develop a quarantine procedure for incoming animals"
• "@atomicai create a controlled substance log for veterinary use"

Getting Started

1. Review IACUC Requirements - Align policies with your institutional IACUC
2. Customize Species SOPs - Adapt procedures for your animal models
3. Set Up Health Monitoring - Configure veterinary observation forms
4. Establish Environmental Controls - Implement monitoring logs
5. Train Personnel - Use competency assessment forms

Key Documents to Create First

1. Animal Health Monitoring SOP - Foundation for veterinary oversight
2. Euthanasia Policy - AVMA-compliant methods by species
3. Environmental Enrichment Program - Species-specific enrichment plans
4. IACUC Protocol Template - Standardized protocol submission format
5. Post-Procedure Monitoring Form - Observation and scoring records
6. Occupational Health Program - Staff safety and zoonosis prevention
7. Sanitation and Cage Wash SOP - Facility hygiene procedures

Special Considerations for Animal Research

Species-Specific Requirements

• Housing density and cage dimensions
• Environmental parameters (temp, humidity, lighting)
• Dietary requirements and feeding schedules
• Social housing and compatibility
• Enrichment appropriate to natural behaviors

Veterinary Care

• Regular health monitoring schedules
• Pain and distress assessment scales
• Anesthesia and analgesia protocols
• Humane endpoints and euthanasia criteria
• Emergency veterinary coverage

Regulatory Compliance

• IACUC protocol approval and amendments
• Annual protocol reviews and renewals
• Semi-annual facility inspections
• USDA annual reports (covered species)
• Personnel training documentation

Biosafety and Occupational Health

• Zoonotic disease prevention
• Allergen exposure monitoring
• Personal protective equipment
• Hazardous agent handling (if applicable)
• Medical surveillance program

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This template is maintained by AtomicQMS. For questions, open an issue in this repository.