Sync template from atomicqms-style deployment

Forms/FRM-001-Document-Change-Request.md

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+# Document Change Request Form
+
+| Form ID | FRM-001 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Request Information
+
+| Field | Entry |
+|-------|-------|
+| Request Date | |
+| Requested By | |
+| Department | |
+
+## Section 2: Document Information
+
+| Field | Entry |
+|-------|-------|
+| Document Number | |
+| Document Title | |
+| Current Revision | |
+
+## Section 3: Change Description
+
+### Type of Change
+- [ ] New Document
+- [ ] Revision to Existing Document
+- [ ] Document Obsolescence
+
+### Description of Change
+*(Describe the proposed change in detail)*
+
+
+
+
+### Reason for Change
+*(Explain why this change is needed)*
+
+
+
+
+## Section 4: Impact Assessment
+
+### Affected Areas
+- [ ] Training Required
+- [ ] Other Documents Affected
+- [ ] Process Changes Required
+- [ ] Validation Impact
+
+### List Affected Documents
+
+
+## Section 5: Approvals
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Requester | | | |
+| Document Owner | | | |
+| Quality Assurance | | | |
+
+---
+
+*Form FRM-001 Rev 1.0*

Forms/FRM-003-CAPA-Form.md

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+# Corrective and Preventive Action (CAPA) Form
+
+| Form ID | FRM-003 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: CAPA Identification
+
+| Field | Entry |
+|-------|-------|
+| CAPA Number | |
+| Date Initiated | |
+| Initiated By | |
+| CAPA Owner | |
+| Target Closure Date | |
+
+## Section 2: Classification
+
+### Type
+- [ ] Corrective Action
+- [ ] Preventive Action
+
+### Source
+- [ ] Customer Complaint
+- [ ] Internal Audit
+- [ ] External Audit
+- [ ] Process Deviation
+- [ ] Nonconforming Product
+- [ ] Management Review
+- [ ] Other: ____________
+
+### Priority
+- [ ] Critical (5 business days)
+- [ ] Major (15 business days)
+- [ ] Minor (30 business days)
+
+## Section 3: Problem Description
+
+*(Describe the nonconformity or potential nonconformity)*
+
+
+
+
+## Section 4: Immediate Containment
+
+*(Actions taken to contain the immediate impact)*
+
+
+
+
+## Section 5: Root Cause Investigation
+
+### Investigation Method Used
+- [ ] 5 Whys
+- [ ] Fishbone Diagram
+- [ ] Fault Tree Analysis
+- [ ] Other: ____________
+
+### Root Cause Determination
+
+
+
+
+## Section 6: Corrective/Preventive Actions
+
+| Action | Responsible | Due Date | Status |
+|--------|-------------|----------|--------|
+| | | | |
+| | | | |
+| | | | |
+
+## Section 7: Effectiveness Verification
+
+| Criteria | Method | Result |
+|----------|--------|--------|
+| | | |
+
+Verification Date: ____________
+Verified By: ____________
+
+## Section 8: Closure
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| CAPA Owner | | | |
+| Quality Approval | | | |
+
+---
+
+*Form FRM-003 Rev 1.0*

Forms/FRM-006-Audit-Checklist.md

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+# Internal Audit Checklist
+
+| Form ID | FRM-006 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Audit Information
+
+| Field | Entry |
+|-------|-------|
+| Audit Number | |
+| Audit Date | |
+| Area/Process Audited | |
+| Lead Auditor | |
+| Auditee(s) | |
+
+---
+
+## Checklist Items
+
+| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
+|---|---------------------|-----------|---------|----------------|
+| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
+| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
+| 3 | Are training records current and complete? | SOP-003 | | |
+| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
+| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
+| 6 | Are CAPAs being completed on time? | SOP-002 | | |
+| 7 | Is equipment calibrated and maintained? | | | |
+| 8 | Are process controls being followed? | | | |
+| 9 | Are quality objectives being monitored? | | | |
+| 10 | | | | |
+
+**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
+
+---
+
+## Findings Summary
+
+| Finding # | Type | Description | Clause Reference |
+|-----------|------|-------------|------------------|
+| | | | |
+| | | | |
+
+---
+
+## Auditor Signature
+
+| Auditor | Signature | Date |
+|---------|-----------|------|
+| | | |
+
+---
+
+*Form FRM-006 Rev 1.0*

Forms/Training/FRM-004-Training-Record.md

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+# Training Record Form
+
+| Form ID | FRM-004 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Employee Information
+
+| Field | Entry |
+|-------|-------|
+| Employee Name | |
+| Employee ID | |
+| Department | |
+| Job Title | |
+
+## Section 2: Training Information
+
+| Field | Entry |
+|-------|-------|
+| Training Title | |
+| Training Date | |
+| Training Duration | |
+| Trainer Name | |
+| Trainer Qualification | |
+
+### Training Type
+- [ ] Initial Training
+- [ ] Retraining
+- [ ] Refresher
+- [ ] Procedure Update
+
+### Delivery Method
+- [ ] Classroom
+- [ ] On-the-Job
+- [ ] Self-Study
+- [ ] Computer-Based
+- [ ] Other: ____________
+
+## Section 3: Training Content
+
+*(List topics covered or attach training materials)*
+
+
+
+
+## Section 4: Assessment
+
+### Assessment Method
+- [ ] Written Test
+- [ ] Practical Demonstration
+- [ ] Verbal Assessment
+- [ ] Observation
+
+### Assessment Results
+
+| Metric | Result |
+|--------|--------|
+| Score (if applicable) | |
+| Pass/Fail | |
+
+## Section 5: Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Trainee | | | |
+| Trainer | | | |
+| Supervisor | | | |
+
+---
+
+*Form FRM-004 Rev 1.0*

Forms/Treatment-Logs/FRM-TMS-001-Treatment-Session-Log.md

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+# TMS Treatment Session Log
+
+| Form ID | FRM-TMS-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Patient Information
+
+| Field | Entry |
+|-------|-------|
+| Patient Name | |
+| MRN | |
+| Date of Birth | |
+| Diagnosis | ☐ MDD ☐ OCD ☐ Other: _______ |
+| Treatment Protocol | ☐ Standard rTMS ☐ iTBS ☐ Other: _______ |
+| Prescribing Physician | |
+
+---
+
+## Session Information
+
+| Field | Entry |
+|-------|-------|
+| Date | |
+| Session Number | ____ of ____ |
+| Start Time | |
+| End Time | |
+| Operator Name | |
+| Operator Credentials | |
+
+---
+
+## Pre-Treatment Assessment
+
+### Daily Safety Screening
+
+| Question | Response |
+|----------|----------|
+| Any new medications since last session? | ☐ Yes (list below) ☐ No |
+| Any changes to existing medications? | ☐ Yes (list below) ☐ No |
+| Did you get at least 4 hours of sleep? | ☐ Yes ☐ No |
+| Any alcohol in past 24 hours? | ☐ Yes (amount: _____) ☐ No |
+| Any recreational drugs? | ☐ Yes ☐ No |
+| Any new medical symptoms or illness? | ☐ Yes (describe below) ☐ No |
+| Any problems since last treatment? | ☐ Yes (describe below) ☐ No |
+
+**Notes on positive responses:**
+
+---
+
+### Vital Signs (if indicated)
+
+| Parameter | Value |
+|-----------|-------|
+| Blood Pressure | / mmHg |
+| Heart Rate | bpm |
+
+---
+
+## Treatment Parameters
+
+### Motor Threshold
+
+| Field | Entry |
+|-------|-------|
+| Motor Threshold (%) | |
+| MT Determination Date | |
+| Rechecked This Session? | ☐ Yes ☐ No |
+
+### Stimulation Parameters
+
+| Parameter | Prescribed | Delivered |
+|-----------|------------|-----------|
+| Target Site | | |
+| Coil Type | | |
+| Frequency (Hz) | | |
+| Intensity (% MT) | | |
+| Pulses per Train | | |
+| Inter-Train Interval (sec) | | |
+| Number of Trains | | |
+| Total Pulses | | |
+| Session Duration | | |
+
+### Coil Position
+
+| Field | Entry |
+|-------|-------|
+| Positioning Method | ☐ 5-cm Rule ☐ Neuronavigation ☐ Other |
+| Coil Position Verified? | ☐ Yes |
+| Coil Angle | |
+| Position Markings Used? | ☐ Yes ☐ No |
+
+---
+
+## Treatment Delivery
+
+| Field | Entry |
+|-------|-------|
+| Full Treatment Delivered? | ☐ Yes ☐ No |
+| If No, Reason | |
+| If No, Pulses Delivered | |
+
+### Interruptions (if any)
+
+| Time | Duration | Reason |
+|------|----------|--------|
+| | | |
+| | | |
+
+---
+
+## Patient Tolerance
+
+### During Treatment
+
+| Symptom | Present? | Severity (1-10) | Notes |
+|---------|----------|-----------------|-------|
+| Scalp pain/discomfort | ☐ Yes ☐ No | | |
+| Facial twitching | ☐ Yes ☐ No | | |
+| Neck pain | ☐ Yes ☐ No | | |
+| Dizziness/lightheadedness | ☐ Yes ☐ No | | |
+| Anxiety | ☐ Yes ☐ No | | |
+| Other: | ☐ Yes ☐ No | | |
+
+**Comfort Measures Used:**
+☐ Repositioning  ☐ Intensity adjustment  ☐ Break taken  ☐ Other: _______
+
+### Post-Treatment Assessment
+
+| Symptom | Present? | Severity (1-10) |
+|---------|----------|-----------------|
+| Headache | ☐ Yes ☐ No | |
+| Scalp tenderness | ☐ Yes ☐ No | |
+| Fatigue | ☐ Yes ☐ No | |
+| Difficulty concentrating | ☐ Yes ☐ No | |
+| Other: | ☐ Yes ☐ No | |
+
+### Overall Tolerance Rating
+
+☐ Excellent - No discomfort
+☐ Good - Mild, tolerable discomfort
+☐ Fair - Moderate discomfort requiring intervention
+☐ Poor - Significant discomfort, treatment modified
+☐ Intolerable - Treatment stopped early
+
+---
+
+## Adverse Events
+
+☐ No adverse events this session
+
+| Event | Details |
+|-------|---------|
+| Description | |
+| Time of Onset | |
+| Duration | |
+| Severity | ☐ Mild ☐ Moderate ☐ Severe |
+| Action Taken | |
+| Resolved? | ☐ Yes ☐ No ☐ Ongoing |
+| Physician Notified? | ☐ Yes ☐ No ☐ N/A |
+| Physician Name/Time | |
+
+**Adverse Event Report Filed?** ☐ Yes (Report #: _____) ☐ No ☐ N/A
+
+---
+
+## Clinical Observations
+
+**Patient's subjective report of symptom change:**
+☐ Much worse  ☐ Somewhat worse  ☐ No change  ☐ Somewhat better  ☐ Much better
+
+**Comments:**
+
+---
+
+## Weekly Outcome Assessment (if applicable)
+
+| Assessment | Score | Date |
+|------------|-------|------|
+| PHQ-9 | | |
+| HAM-D | | |
+| Y-BOCS | | |
+| Other: | | |
+
+---
+
+## Equipment
+
+| Field | Entry |
+|-------|-------|
+| Device Model/Serial # | |
+| Coil Serial # | |
+| Equipment Functioning Normally? | ☐ Yes ☐ No |
+| Issues Noted | |
+
+---
+
+## Next Session
+
+| Field | Entry |
+|-------|-------|
+| Next Appointment Date | |
+| Next Appointment Time | |
+| Parameters to Modify? | ☐ Yes (describe) ☐ No |
+| MT Recheck Needed? | ☐ Yes ☐ No |
+| Physician Review Needed? | ☐ Yes ☐ No |
+
+---
+
+## Signatures
+
+### Operator Attestation
+
+I certify that this treatment session was administered in accordance with the prescribed protocol and documented accurately.
+
+| Field | Entry |
+|-------|-------|
+| Operator Signature | |
+| Date | |
+| Time | |
+
+### Supervising Physician Review (if required)
+
+| Field | Entry |
+|-------|-------|
+| Physician Signature | |
+| Date | |
+| Comments | |
+
+---
+
+*Form FRM-TMS-001 Rev 1.0 - TMS Treatment Session Log*