135 lines
5.8 KiB
Markdown
135 lines
5.8 KiB
Markdown
# Animal Research Facility Quality Management System
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A comprehensive QMS template designed for animal research facilities, vivaria, and laboratory animal care programs supporting biomedical research.
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## 🐭 Designed For
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- **Academic Vivaria** - University and medical center animal facilities
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- **Pharmaceutical Research** - Drug discovery and preclinical testing facilities
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- **Contract Research Organizations (CROs)** - Animal study service providers
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- **Biotechnology Companies** - Research and development animal programs
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- **Government Research Facilities** - NIH, CDC, and agency research programs
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- **Veterinary Schools** - Teaching and research animal programs
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- **Breeding Colonies** - Specialized genetic model production facilities
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **PHS Policy** - Public Health Service Policy on Humane Care and Use of Laboratory Animals
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- **USDA/AWA** - Animal Welfare Act and Regulations (9 CFR Parts 1-4)
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- **AAALAC** - Association for Assessment and Accreditation of Laboratory Animal Care International
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- **IACUC** - Institutional Animal Care and Use Committee requirements
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- **Guide for the Care and Use of Laboratory Animals** (8th Edition)
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- **AVMA Guidelines** - Euthanasia and veterinary care standards
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- **OLAW** - Office of Laboratory Animal Welfare requirements
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- **GLP** - Good Laboratory Practice for regulated studies (21 CFR Part 58)
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- **OSHA** - Occupational safety for animal handlers
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- **CDC/NIH BMBL** - Biosafety in Microbiological and Biomedical Laboratories
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## Repository Structure
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```
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├── SOPs/
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│ ├── Animal-Care/ # Daily care, feeding, environmental enrichment
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│ ├── Veterinary-Services/ # Health monitoring, treatments, euthanasia
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│ ├── Colony-Management/ # Breeding, genetics, census tracking
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│ ├── Facility-Operations/ # Sanitation, cage wash, environmental controls
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│ ├── Safety/ # Zoonosis, allergens, occupational health
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│ └── General/ # Document control, training, CAPA
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├── Forms/
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│ ├── IACUC-Protocols/ # Protocol submission and amendment forms
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│ ├── Health-Records/ # Veterinary treatment and observation logs
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│ ├── Census-Tracking/ # Animal inventory and disposition records
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│ ├── Environmental/ # Temperature, humidity, light cycle logs
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│ ├── Training/ # Competency assessments, certifications
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│ └── Incident-Reports/ # Adverse events, protocol deviations
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├── Policies/ # Institutional policies and IACUC guidelines
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├── Work-Instructions/ # Step-by-step procedures
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└── Templates/ # Document templates
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```
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-AC-XXX**: Animal Care SOPs
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- **SOP-VET-XXX**: Veterinary Services SOPs
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- **SOP-COL-XXX**: Colony Management SOPs
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- **SOP-FAC-XXX**: Facility Operations SOPs
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- **SOP-SAF-XXX**: Safety SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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- **PRO-XXX**: IACUC Protocol Templates
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your animal facility QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft species-specific SOPs for animal care and handling
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- Create IACUC protocol templates and amendments
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- Generate veterinary treatment and monitoring procedures
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- Develop environmental enrichment programs
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- Create biosafety and occupational health procedures
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- Review documents for regulatory compliance
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### Example Prompts
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- "@atomicai create an SOP for rodent health monitoring per the Guide"
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- "@atomicai draft a post-operative care procedure for surgical models"
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- "@atomicai write an environmental enrichment policy for NHPs"
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- "@atomicai create an IACUC annual review checklist"
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- "@atomicai develop a quarantine procedure for incoming animals"
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- "@atomicai create a controlled substance log for veterinary use"
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## Getting Started
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1. **Review IACUC Requirements** - Align policies with your institutional IACUC
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2. **Customize Species SOPs** - Adapt procedures for your animal models
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3. **Set Up Health Monitoring** - Configure veterinary observation forms
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4. **Establish Environmental Controls** - Implement monitoring logs
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5. **Train Personnel** - Use competency assessment forms
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## Key Documents to Create First
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1. **Animal Health Monitoring SOP** - Foundation for veterinary oversight
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2. **Euthanasia Policy** - AVMA-compliant methods by species
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3. **Environmental Enrichment Program** - Species-specific enrichment plans
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4. **IACUC Protocol Template** - Standardized protocol submission format
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5. **Post-Procedure Monitoring Form** - Observation and scoring records
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6. **Occupational Health Program** - Staff safety and zoonosis prevention
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7. **Sanitation and Cage Wash SOP** - Facility hygiene procedures
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## Special Considerations for Animal Research
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### Species-Specific Requirements
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- Housing density and cage dimensions
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- Environmental parameters (temp, humidity, lighting)
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- Dietary requirements and feeding schedules
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- Social housing and compatibility
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- Enrichment appropriate to natural behaviors
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### Veterinary Care
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- Regular health monitoring schedules
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- Pain and distress assessment scales
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- Anesthesia and analgesia protocols
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- Humane endpoints and euthanasia criteria
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- Emergency veterinary coverage
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### Regulatory Compliance
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- IACUC protocol approval and amendments
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- Annual protocol reviews and renewals
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- Semi-annual facility inspections
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- USDA annual reports (covered species)
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- Personnel training documentation
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### Biosafety and Occupational Health
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- Zoonotic disease prevention
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- Allergen exposure monitoring
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- Personal protective equipment
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- Hazardous agent handling (if applicable)
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- Medical surveillance program
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---
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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
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