Sync template from atomicqms-style deployment
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Forms/Census-Tracking/.gitkeep
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Forms/Census-Tracking/.gitkeep
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Forms/Environmental/.gitkeep
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Forms/Environmental/.gitkeep
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64
Forms/FRM-001-Document-Change-Request.md
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Forms/FRM-001-Document-Change-Request.md
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# Document Change Request Form
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| Form ID | FRM-001 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: Request Information
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| Field | Entry |
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|-------|-------|
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| Request Date | |
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| Requested By | |
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| Department | |
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## Section 2: Document Information
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| Field | Entry |
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|-------|-------|
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| Document Number | |
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| Document Title | |
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| Current Revision | |
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## Section 3: Change Description
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### Type of Change
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- [ ] New Document
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- [ ] Revision to Existing Document
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- [ ] Document Obsolescence
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### Description of Change
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*(Describe the proposed change in detail)*
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### Reason for Change
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*(Explain why this change is needed)*
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## Section 4: Impact Assessment
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### Affected Areas
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- [ ] Training Required
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- [ ] Other Documents Affected
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- [ ] Process Changes Required
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- [ ] Validation Impact
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### List Affected Documents
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## Section 5: Approvals
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Requester | | | |
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| Document Owner | | | |
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| Quality Assurance | | | |
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---
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*Form FRM-001 Rev 1.0*
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Forms/FRM-003-CAPA-Form.md
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Forms/FRM-003-CAPA-Form.md
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# Corrective and Preventive Action (CAPA) Form
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| Form ID | FRM-003 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: CAPA Identification
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| Field | Entry |
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|-------|-------|
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| CAPA Number | |
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| Date Initiated | |
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| Initiated By | |
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| CAPA Owner | |
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| Target Closure Date | |
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## Section 2: Classification
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### Type
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- [ ] Corrective Action
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- [ ] Preventive Action
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### Source
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- [ ] Customer Complaint
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- [ ] Internal Audit
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- [ ] External Audit
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- [ ] Process Deviation
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- [ ] Nonconforming Product
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- [ ] Management Review
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- [ ] Other: ____________
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### Priority
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- [ ] Critical (5 business days)
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- [ ] Major (15 business days)
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- [ ] Minor (30 business days)
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## Section 3: Problem Description
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*(Describe the nonconformity or potential nonconformity)*
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## Section 4: Immediate Containment
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*(Actions taken to contain the immediate impact)*
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## Section 5: Root Cause Investigation
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### Investigation Method Used
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- [ ] 5 Whys
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- [ ] Fishbone Diagram
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- [ ] Fault Tree Analysis
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- [ ] Other: ____________
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### Root Cause Determination
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## Section 6: Corrective/Preventive Actions
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| Action | Responsible | Due Date | Status |
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|--------|-------------|----------|--------|
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| | | | |
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| | | | |
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| | | | |
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## Section 7: Effectiveness Verification
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| Criteria | Method | Result |
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|----------|--------|--------|
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| | | |
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Verification Date: ____________
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Verified By: ____________
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## Section 8: Closure
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| CAPA Owner | | | |
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| Quality Approval | | | |
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---
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*Form FRM-003 Rev 1.0*
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Forms/FRM-006-Audit-Checklist.md
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Forms/FRM-006-Audit-Checklist.md
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# Internal Audit Checklist
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| Form ID | FRM-006 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Audit Information
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| Field | Entry |
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|-------|-------|
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| Audit Number | |
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| Audit Date | |
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| Area/Process Audited | |
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| Lead Auditor | |
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| Auditee(s) | |
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---
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## Checklist Items
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| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
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|---|---------------------|-----------|---------|----------------|
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| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
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| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
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| 3 | Are training records current and complete? | SOP-003 | | |
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| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
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| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
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| 6 | Are CAPAs being completed on time? | SOP-002 | | |
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| 7 | Is equipment calibrated and maintained? | | | |
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| 8 | Are process controls being followed? | | | |
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| 9 | Are quality objectives being monitored? | | | |
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| 10 | | | | |
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**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
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---
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## Findings Summary
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| Finding # | Type | Description | Clause Reference |
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|-----------|------|-------------|------------------|
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---
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## Auditor Signature
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| Auditor | Signature | Date |
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|---------|-----------|------|
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---
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*Form FRM-006 Rev 1.0*
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Forms/Health-Records/.gitkeep
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Forms/Health-Records/.gitkeep
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Forms/Health-Records/FRM-VET-001-Daily-Health-Check.md
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Forms/Health-Records/FRM-VET-001-Daily-Health-Check.md
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# Daily Animal Health Check
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| Form ID | FRM-VET-001 | Revision | 1.0 |
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|---------|-------------|----------|-----|
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---
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## Room/Area Information
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| Field | Entry |
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|-------|-------|
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| Room Number | |
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| Species | |
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| Date | |
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| Observer Name | |
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| Observer Initials | |
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## Health Observation Checklist
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For each cage/pen, check off normal observations. Circle and note any abnormalities.
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### General Colony Status
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- [ ] All animals present and accounted for
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- [ ] No mortalities observed
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- [ ] HVAC functioning (temp/humidity in range)
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- [ ] Lighting on appropriate cycle
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- [ ] No unusual odors
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### Individual Cage Assessment
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| Cage # | Animals OK | Food OK | Water OK | Abnormalities Noted |
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|--------|------------|---------|----------|---------------------|
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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| | ☐ | ☐ | ☐ | |
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## Abnormality Details
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If any abnormalities noted above, provide details:
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### Animal 1
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| Field | Entry |
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|-------|-------|
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| Cage # | |
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| Animal ID | |
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| Protocol # | |
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| PI Name | |
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| Clinical Signs Observed | |
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| Action Taken | |
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| Vet Notified? | ☐ Yes ☐ No |
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| Vet Name/Time | |
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### Animal 2
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| Field | Entry |
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|-------|-------|
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| Cage # | |
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| Animal ID | |
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| Protocol # | |
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| PI Name | |
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| Clinical Signs Observed | |
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| Action Taken | |
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| Vet Notified? | ☐ Yes ☐ No |
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| Vet Name/Time | |
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## Clinical Signs Reference
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Check all that apply for abnormal animals:
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**Appearance**
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- [ ] Rough/unkempt coat
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- [ ] Hunched posture
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- [ ] Piloerection
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- [ ] Lethargy
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- [ ] Weight loss visible
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**Respiratory**
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- [ ] Labored breathing
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- [ ] Nasal discharge
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- [ ] Open-mouth breathing
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**GI/Elimination**
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- [ ] Diarrhea
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- [ ] Blood in stool
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- [ ] Bloated abdomen
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**Neurological**
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- [ ] Circling
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- [ ] Head tilt
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- [ ] Seizures
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- [ ] Ataxia
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**Other**
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- [ ] Wounds/lesions
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- [ ] Eye abnormalities
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- [ ] Tumor growth
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- [ ] Other: _______________
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## Environmental Observations
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| Parameter | Reading | Normal Range | OK? |
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|-----------|---------|--------------|-----|
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| Temperature | °F/°C | Species-specific | ☐ |
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| Humidity | % | 30-70% | ☐ |
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| Light Cycle | :00 - :00 | Per protocol | ☐ |
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Environmental concerns noted:
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_______________________________________________
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## Completion Verification
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| Field | Entry |
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|-------|-------|
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| All cages checked? | ☐ Yes |
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| All abnormalities documented? | ☐ Yes ☐ N/A |
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| Vet notified of concerns? | ☐ Yes ☐ N/A |
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| Observer Signature | |
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| Time Completed | |
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## Supervisor Review (if abnormalities noted)
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| Field | Entry |
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|-------|-------|
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| Reviewed By | |
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| Date | |
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| Comments | |
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---
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*Form FRM-VET-001 Rev 1.0 - Daily Animal Health Check*
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0
Forms/IACUC-Protocols/.gitkeep
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0
Forms/IACUC-Protocols/.gitkeep
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0
Forms/Incident-Reports/.gitkeep
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0
Forms/Incident-Reports/.gitkeep
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72
Forms/Training/FRM-004-Training-Record.md
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Forms/Training/FRM-004-Training-Record.md
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# Training Record Form
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| Form ID | FRM-004 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: Employee Information
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| Field | Entry |
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|-------|-------|
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| Employee Name | |
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| Employee ID | |
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| Department | |
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| Job Title | |
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## Section 2: Training Information
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| Field | Entry |
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|-------|-------|
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| Training Title | |
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| Training Date | |
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| Training Duration | |
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| Trainer Name | |
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| Trainer Qualification | |
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### Training Type
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- [ ] Initial Training
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- [ ] Retraining
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- [ ] Refresher
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- [ ] Procedure Update
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### Delivery Method
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- [ ] Classroom
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- [ ] On-the-Job
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- [ ] Self-Study
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- [ ] Computer-Based
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- [ ] Other: ____________
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## Section 3: Training Content
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*(List topics covered or attach training materials)*
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## Section 4: Assessment
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### Assessment Method
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- [ ] Written Test
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- [ ] Practical Demonstration
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- [ ] Verbal Assessment
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- [ ] Observation
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### Assessment Results
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| Metric | Result |
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|--------|--------|
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| Score (if applicable) | |
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| Pass/Fail | |
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## Section 5: Signatures
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Trainee | | | |
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| Trainer | | | |
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| Supervisor | | | |
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---
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*Form FRM-004 Rev 1.0*
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Reference in New Lab Ticket
Block a user