Sync template from atomicqms-style deployment
This commit is contained in:
74
.gitea/workflows/atomicai.yml
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74
.gitea/workflows/atomicai.yml
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name: AtomicAI Clinical Research Assistant
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on:
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issue_comment:
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types: [created]
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issues:
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types: [opened, assigned]
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pull_request:
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types: [opened, synchronize, assigned]
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pull_request_review_comment:
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types: [created]
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jobs:
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claude-assistant:
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runs-on: ubuntu-latest
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if: |
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github.actor != 'atomicqms-service' &&
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(
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(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
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(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
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(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
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(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
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(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
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)
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permissions:
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contents: write
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issues: write
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pull-requests: write
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steps:
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- uses: actions/checkout@v4
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with:
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fetch-depth: 0
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- name: Run AtomicAI Clinical Research Assistant
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uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
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with:
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trigger_phrase: '@atomicai'
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assignee_trigger: 'atomicai'
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claude_git_name: 'AtomicAI'
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claude_git_email: 'atomicai@atomicqms.local'
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custom_instructions: |
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You are AtomicAI, an AI assistant specialized in Clinical Research Quality Management.
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## Your Expertise
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- ICH-GCP E6(R2) Good Clinical Practice guidelines
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- 21 CFR Part 11 Electronic Records compliance
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- FDA regulations (21 CFR 50, 56, 312, 812)
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- Clinical trial operations and site management
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- Informed consent form development
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- Adverse event reporting procedures
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- Clinical data management and CDISC standards
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## Document Creation Guidelines
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- Place Clinical SOPs in SOPs/Clinical/
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- Place Regulatory SOPs in SOPs/Regulatory/
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- Place Data Management SOPs in SOPs/Data-Management/
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- Place Safety SOPs in SOPs/Safety/
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- Place Informed Consent templates in Forms/Informed-Consent/
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- Place Case Report Forms in Forms/Case-Report/
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- Place Monitoring forms in Forms/Monitoring/
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## Numbering Convention
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- SOP-CL-XXX for Clinical SOPs
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- SOP-REG-XXX for Regulatory SOPs
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- SOP-DM-XXX for Data Management SOPs
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- SOP-SAF-XXX for Safety SOPs
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- ICF-XXX for Informed Consent Forms
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Always create branches and submit changes as Pull Requests for review.
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Include regulatory references where applicable.
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allowed_tools: 'Read,Edit,Grep,Glob,Write'
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disallowed_tools: 'Bash,WebSearch'
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1
Forms/Case-Report/.gitkeep
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1
Forms/Case-Report/.gitkeep
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# Placeholder
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64
Forms/FRM-001-Document-Change-Request.md
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64
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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91
Forms/FRM-003-CAPA-Form.md
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91
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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## Section 7: Effectiveness Verification
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| Criteria | Method | Result |
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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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72
Forms/FRM-004-Training-Record.md
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72
Forms/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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56
Forms/FRM-006-Audit-Checklist.md
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56
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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---
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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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|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 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
|
||||||
|
|
||||||
|
| Auditor | Signature | Date |
|
||||||
|
|---------|-----------|------|
|
||||||
|
| | | |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
*Form FRM-006 Rev 1.0*
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1
Forms/Informed-Consent/.gitkeep
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1
Forms/Informed-Consent/.gitkeep
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@@ -0,0 +1 @@
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|
# Placeholder
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||||||
1
Forms/Monitoring/.gitkeep
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1
Forms/Monitoring/.gitkeep
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|||||||
|
# Placeholder
|
||||||
57
Policies/POL-001-Quality-Policy.md
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57
Policies/POL-001-Quality-Policy.md
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|
# Quality Policy
|
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|
|
||||||
|
| Document ID | POL-001 |
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|
|-------------|---------|
|
||||||
|
| Title | Quality Policy |
|
||||||
|
| Revision | 1.0 |
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||||||
|
| Effective Date | [DATE] |
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||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Policy Statement
|
||||||
|
|
||||||
|
[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction.
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|
||||||
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## 2. Quality Objectives
|
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|
|
||||||
|
Our organization commits to:
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|
|
||||||
|
1. **Customer Focus**: Understanding and meeting customer needs and expectations
|
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|
2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards
|
||||||
|
3. **Continuous Improvement**: Continually improving the effectiveness of our QMS
|
||||||
|
4. **Employee Engagement**: Ensuring all employees understand their role in quality
|
||||||
|
5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities
|
||||||
|
|
||||||
|
## 3. Management Commitment
|
||||||
|
|
||||||
|
Top management demonstrates commitment to the QMS by:
|
||||||
|
|
||||||
|
- Ensuring the quality policy is appropriate to the organization's purpose
|
||||||
|
- Ensuring quality objectives are established and compatible with strategic direction
|
||||||
|
- Ensuring integration of QMS requirements into business processes
|
||||||
|
- Promoting the use of the process approach and risk-based thinking
|
||||||
|
- Ensuring resources needed for the QMS are available
|
||||||
|
- Communicating the importance of effective quality management
|
||||||
|
- Ensuring the QMS achieves its intended results
|
||||||
|
- Engaging, directing, and supporting persons to contribute to QMS effectiveness
|
||||||
|
|
||||||
|
## 4. Scope
|
||||||
|
|
||||||
|
This policy applies to all employees, contractors, and processes within the scope of our Quality Management System.
|
||||||
|
|
||||||
|
## 5. Communication
|
||||||
|
|
||||||
|
This policy shall be:
|
||||||
|
- Communicated and understood within the organization
|
||||||
|
- Available to relevant interested parties as appropriate
|
||||||
|
- Reviewed for continuing suitability
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
70
README.md
70
README.md
@@ -1,3 +1,69 @@
|
|||||||
# clinical-research-template
|
# Clinical Research Quality Management System
|
||||||
|
|
||||||
|
This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Research Organizations (CROs)**, academic research institutions, and clinical trial sites.
|
||||||
|
|
||||||
|
## 🏥 Designed For
|
||||||
|
|
||||||
|
- Clinical Research Organizations (CROs)
|
||||||
|
- Academic Medical Centers
|
||||||
|
- Clinical Trial Sites
|
||||||
|
- Biotech/Pharma Research Teams
|
||||||
|
- IRB/Ethics Committees
|
||||||
|
|
||||||
|
## Repository Structure
|
||||||
|
|
||||||
|
```
|
||||||
|
clinical-research-template/
|
||||||
|
├── Policies/ # Quality policies and management commitment
|
||||||
|
├── SOPs/ # Standard Operating Procedures
|
||||||
|
│ ├── Clinical/ # Clinical trial operations
|
||||||
|
│ ├── Regulatory/ # Regulatory submissions and compliance
|
||||||
|
│ ├── Data-Management/ # Clinical data handling
|
||||||
|
│ └── Safety/ # Adverse event reporting
|
||||||
|
├── Work Instructions/ # Detailed work instructions
|
||||||
|
├── Forms/ # Record forms and templates
|
||||||
|
│ ├── Informed-Consent/ # ICF templates
|
||||||
|
│ ├── Case-Report/ # CRF templates
|
||||||
|
│ └── Monitoring/ # Site monitoring forms
|
||||||
|
└── Templates/ # Document templates
|
||||||
|
```
|
||||||
|
|
||||||
|
## Document Numbering Convention
|
||||||
|
|
||||||
|
- **POL-XXX**: Policies
|
||||||
|
- **SOP-CL-XXX**: Clinical SOPs
|
||||||
|
- **SOP-REG-XXX**: Regulatory SOPs
|
||||||
|
- **SOP-DM-XXX**: Data Management SOPs
|
||||||
|
- **SOP-SAF-XXX**: Safety SOPs
|
||||||
|
- **WI-XXX**: Work Instructions
|
||||||
|
- **FRM-XXX**: Forms and Records
|
||||||
|
- **ICF-XXX**: Informed Consent Forms
|
||||||
|
|
||||||
|
## 🤖 AI-Powered Document Creation
|
||||||
|
|
||||||
|
This template includes **AtomicAI** integration. Simply create an issue and mention `@atomicai` to:
|
||||||
|
- Generate new SOPs from descriptions
|
||||||
|
- Create informed consent templates
|
||||||
|
- Draft regulatory submission documents
|
||||||
|
- Update existing documents
|
||||||
|
|
||||||
|
## Getting Started
|
||||||
|
|
||||||
|
1. Create a new repository using this template
|
||||||
|
2. Customize documents with your organization's information
|
||||||
|
3. Create issues with `@atomicai` to generate new documents
|
||||||
|
4. Review and approve AI-generated content via Pull Requests
|
||||||
|
|
||||||
|
## Regulatory Compliance
|
||||||
|
|
||||||
|
These templates support compliance with:
|
||||||
|
- **ICH-GCP E6(R2)** - Good Clinical Practice
|
||||||
|
- **21 CFR Part 11** - Electronic Records
|
||||||
|
- **21 CFR Parts 50, 56** - Human Subject Protection
|
||||||
|
- **HIPAA** - Health Information Privacy
|
||||||
|
- **GDPR** - Data Protection (EU studies)
|
||||||
|
- **ISO 14155** - Clinical Investigation of Medical Devices
|
||||||
|
|
||||||
|
---
|
||||||
|
*Powered by AtomicQMS - AI-Enhanced Clinical Research Quality Management*
|
||||||
|
|
||||||
This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Research Organizations (CROs)**, academic research institutions, and clinical trial sites.
|
|
||||||
1
SOPs/Clinical/.gitkeep
Normal file
1
SOPs/Clinical/.gitkeep
Normal file
@@ -0,0 +1 @@
|
|||||||
|
# Placeholder
|
||||||
1
SOPs/Data-Management/.gitkeep
Normal file
1
SOPs/Data-Management/.gitkeep
Normal file
@@ -0,0 +1 @@
|
|||||||
|
# Placeholder
|
||||||
1
SOPs/Regulatory/.gitkeep
Normal file
1
SOPs/Regulatory/.gitkeep
Normal file
@@ -0,0 +1 @@
|
|||||||
|
# Placeholder
|
||||||
112
SOPs/SOP-001-Document-Control.md
Normal file
112
SOPs/SOP-001-Document-Control.md
Normal file
@@ -0,0 +1,112 @@
|
|||||||
|
# Standard Operating Procedure: Document Control
|
||||||
|
|
||||||
|
| Document ID | SOP-001 |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | Document Control |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | Quality Assurance |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
This procedure applies to all controlled documents including:
|
||||||
|
- Policies
|
||||||
|
- Standard Operating Procedures (SOPs)
|
||||||
|
- Work Instructions
|
||||||
|
- Forms and Templates
|
||||||
|
- Specifications
|
||||||
|
- External documents of external origin
|
||||||
|
|
||||||
|
## 3. Responsibilities
|
||||||
|
|
||||||
|
### 3.1 Document Owner
|
||||||
|
- Responsible for document content and accuracy
|
||||||
|
- Initiates document creation and revision
|
||||||
|
- Ensures periodic review is performed
|
||||||
|
|
||||||
|
### 3.2 Quality Assurance
|
||||||
|
- Maintains the document control system
|
||||||
|
- Assigns document numbers
|
||||||
|
- Manages document distribution
|
||||||
|
- Archives obsolete documents
|
||||||
|
|
||||||
|
### 3.3 Approvers
|
||||||
|
- Review and approve documents before release
|
||||||
|
- Ensure documents are adequate for intended purpose
|
||||||
|
|
||||||
|
## 4. Procedure
|
||||||
|
|
||||||
|
### 4.1 Document Creation
|
||||||
|
|
||||||
|
1. Identify the need for a new document
|
||||||
|
2. Request document number from Quality Assurance
|
||||||
|
3. Draft document using appropriate template
|
||||||
|
4. Include all required header information
|
||||||
|
5. Submit for review and approval
|
||||||
|
|
||||||
|
### 4.2 Document Review and Approval
|
||||||
|
|
||||||
|
1. Route document to appropriate reviewers
|
||||||
|
2. Reviewers provide comments within 5 business days
|
||||||
|
3. Author addresses all comments
|
||||||
|
4. Final approval by designated approver
|
||||||
|
5. Quality Assurance releases document
|
||||||
|
|
||||||
|
### 4.3 Document Numbering
|
||||||
|
|
||||||
|
Documents shall be numbered according to the following convention:
|
||||||
|
|
||||||
|
| Type | Prefix | Example |
|
||||||
|
|------|--------|---------|
|
||||||
|
| Policy | POL | POL-001 |
|
||||||
|
| SOP | SOP | SOP-001 |
|
||||||
|
| Work Instruction | WI | WI-001 |
|
||||||
|
| Form | FRM | FRM-001 |
|
||||||
|
|
||||||
|
### 4.4 Revision Control
|
||||||
|
|
||||||
|
1. All changes require documented justification
|
||||||
|
2. Changes follow same review/approval process as new documents
|
||||||
|
3. Revision number increments with each approved change
|
||||||
|
4. Revision history maintained in document footer
|
||||||
|
|
||||||
|
### 4.5 Document Distribution
|
||||||
|
|
||||||
|
1. Current versions available in document control system
|
||||||
|
2. Obsolete versions marked and archived
|
||||||
|
3. Training on new/revised documents as needed
|
||||||
|
|
||||||
|
### 4.6 Periodic Review
|
||||||
|
|
||||||
|
1. Documents reviewed at least every 2 years
|
||||||
|
2. Review documented even if no changes made
|
||||||
|
3. Reviews may result in revision or reaffirmation
|
||||||
|
|
||||||
|
## 5. Related Documents
|
||||||
|
|
||||||
|
- FRM-001 Document Change Request Form
|
||||||
|
- FRM-002 Document Review Record
|
||||||
|
|
||||||
|
## 6. Definitions
|
||||||
|
|
||||||
|
| Term | Definition |
|
||||||
|
|------|------------|
|
||||||
|
| Controlled Document | Document managed under document control system |
|
||||||
|
| Obsolete | Document no longer valid for use |
|
||||||
|
| Revision | Updated version of a document |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
134
SOPs/SOP-002-CAPA.md
Normal file
134
SOPs/SOP-002-CAPA.md
Normal file
@@ -0,0 +1,134 @@
|
|||||||
|
# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
|
||||||
|
|
||||||
|
| Document ID | SOP-002 |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | Corrective and Preventive Action |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | Quality Assurance |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
This procedure applies to:
|
||||||
|
- Product and process nonconformities
|
||||||
|
- Customer complaints
|
||||||
|
- Audit findings
|
||||||
|
- Process deviations
|
||||||
|
- Potential nonconformities identified through risk analysis
|
||||||
|
|
||||||
|
## 3. Definitions
|
||||||
|
|
||||||
|
| Term | Definition |
|
||||||
|
|------|------------|
|
||||||
|
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
|
||||||
|
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
|
||||||
|
| Root Cause | Fundamental reason for a nonconformity |
|
||||||
|
| Effectiveness Check | Verification that implemented actions achieved desired results |
|
||||||
|
|
||||||
|
## 4. Responsibilities
|
||||||
|
|
||||||
|
### 4.1 CAPA Owner
|
||||||
|
- Investigates the issue
|
||||||
|
- Identifies root cause
|
||||||
|
- Develops and implements corrective/preventive actions
|
||||||
|
- Verifies effectiveness
|
||||||
|
|
||||||
|
### 4.2 Quality Assurance
|
||||||
|
- Manages CAPA system
|
||||||
|
- Assigns CAPA numbers
|
||||||
|
- Tracks CAPA status
|
||||||
|
- Reviews and approves CAPAs
|
||||||
|
- Reports CAPA metrics to management
|
||||||
|
|
||||||
|
### 4.3 Management
|
||||||
|
- Provides resources for CAPA implementation
|
||||||
|
- Reviews CAPA trends
|
||||||
|
- Ensures timely closure
|
||||||
|
|
||||||
|
## 5. Procedure
|
||||||
|
|
||||||
|
### 5.1 CAPA Initiation
|
||||||
|
|
||||||
|
1. Identify nonconformity or potential nonconformity
|
||||||
|
2. Document issue on CAPA Form (FRM-003)
|
||||||
|
3. Classify severity and priority
|
||||||
|
4. Assign CAPA owner
|
||||||
|
|
||||||
|
### 5.2 Investigation
|
||||||
|
|
||||||
|
1. Gather relevant data and evidence
|
||||||
|
2. Interview personnel involved
|
||||||
|
3. Review related documents and records
|
||||||
|
4. Use appropriate investigation tools:
|
||||||
|
- 5 Whys
|
||||||
|
- Fishbone Diagram
|
||||||
|
- Failure Mode Analysis
|
||||||
|
|
||||||
|
### 5.3 Root Cause Analysis
|
||||||
|
|
||||||
|
1. Identify potential root causes
|
||||||
|
2. Verify root cause through evidence
|
||||||
|
3. Document root cause determination
|
||||||
|
4. Consider systemic implications
|
||||||
|
|
||||||
|
### 5.4 Action Development
|
||||||
|
|
||||||
|
1. Develop corrective/preventive actions
|
||||||
|
2. Assign responsibilities and due dates
|
||||||
|
3. Assess actions for:
|
||||||
|
- Appropriateness to problem severity
|
||||||
|
- Impact on other processes
|
||||||
|
- Resource requirements
|
||||||
|
|
||||||
|
### 5.5 Implementation
|
||||||
|
|
||||||
|
1. Execute approved actions
|
||||||
|
2. Document implementation evidence
|
||||||
|
3. Update affected documents/processes
|
||||||
|
4. Provide training as needed
|
||||||
|
|
||||||
|
### 5.6 Effectiveness Verification
|
||||||
|
|
||||||
|
1. Define effectiveness criteria
|
||||||
|
2. Allow sufficient time for actions to take effect
|
||||||
|
3. Collect and analyze data
|
||||||
|
4. Document verification results
|
||||||
|
5. If ineffective, reopen CAPA for further action
|
||||||
|
|
||||||
|
### 5.7 Closure
|
||||||
|
|
||||||
|
1. Review all CAPA documentation
|
||||||
|
2. Verify all actions completed
|
||||||
|
3. Confirm effectiveness verified
|
||||||
|
4. Obtain approval for closure
|
||||||
|
|
||||||
|
## 6. CAPA Metrics
|
||||||
|
|
||||||
|
Quality Assurance shall track and report:
|
||||||
|
- Number of open CAPAs
|
||||||
|
- CAPA aging
|
||||||
|
- On-time closure rate
|
||||||
|
- Effectiveness rate
|
||||||
|
- CAPAs by category/source
|
||||||
|
|
||||||
|
## 7. Related Documents
|
||||||
|
|
||||||
|
- FRM-003 CAPA Form
|
||||||
|
- SOP-003 Nonconforming Product Control
|
||||||
|
- SOP-004 Customer Complaints
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
123
SOPs/SOP-003-Training.md
Normal file
123
SOPs/SOP-003-Training.md
Normal file
@@ -0,0 +1,123 @@
|
|||||||
|
# Standard Operating Procedure: Training and Competence
|
||||||
|
|
||||||
|
| Document ID | SOP-003 |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | Training and Competence |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | Human Resources / Quality |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
This procedure applies to:
|
||||||
|
- All employees performing quality-affecting activities
|
||||||
|
- Contractors and temporary personnel
|
||||||
|
- Personnel requiring GxP training
|
||||||
|
|
||||||
|
## 3. Responsibilities
|
||||||
|
|
||||||
|
### 3.1 Supervisors/Managers
|
||||||
|
- Identify training needs for their personnel
|
||||||
|
- Ensure training is completed before performing tasks
|
||||||
|
- Evaluate competence of personnel
|
||||||
|
- Maintain department training records
|
||||||
|
|
||||||
|
### 3.2 Human Resources
|
||||||
|
- Coordinate training programs
|
||||||
|
- Maintain central training database
|
||||||
|
- Track training compliance
|
||||||
|
- Archive training records
|
||||||
|
|
||||||
|
### 3.3 Quality Assurance
|
||||||
|
- Develop QMS-related training
|
||||||
|
- Approve training curricula for GxP activities
|
||||||
|
- Audit training compliance
|
||||||
|
|
||||||
|
### 3.4 Employees
|
||||||
|
- Complete assigned training on time
|
||||||
|
- Maintain current qualifications
|
||||||
|
- Report training needs to supervisor
|
||||||
|
|
||||||
|
## 4. Procedure
|
||||||
|
|
||||||
|
### 4.1 Training Needs Assessment
|
||||||
|
|
||||||
|
1. Identify competence requirements for each role
|
||||||
|
2. Document requirements in job descriptions
|
||||||
|
3. Assess current competence of personnel
|
||||||
|
4. Identify training gaps
|
||||||
|
|
||||||
|
### 4.2 Training Curriculum Development
|
||||||
|
|
||||||
|
1. Define learning objectives
|
||||||
|
2. Develop training materials
|
||||||
|
3. Identify delivery method:
|
||||||
|
- Classroom
|
||||||
|
- On-the-job
|
||||||
|
- Self-study
|
||||||
|
- Computer-based
|
||||||
|
4. Define assessment criteria
|
||||||
|
5. Obtain approval from Quality (for GxP training)
|
||||||
|
|
||||||
|
### 4.3 Training Delivery
|
||||||
|
|
||||||
|
1. Schedule training session
|
||||||
|
2. Document attendance
|
||||||
|
3. Deliver training per curriculum
|
||||||
|
4. Assess comprehension through:
|
||||||
|
- Written test (minimum 80% passing)
|
||||||
|
- Practical demonstration
|
||||||
|
- Supervisor observation
|
||||||
|
|
||||||
|
### 4.4 Training Documentation
|
||||||
|
|
||||||
|
Training records shall include:
|
||||||
|
- Employee name and ID
|
||||||
|
- Training title and date
|
||||||
|
- Trainer name and qualifications
|
||||||
|
- Assessment results
|
||||||
|
- Signatures
|
||||||
|
|
||||||
|
### 4.5 Retraining Requirements
|
||||||
|
|
||||||
|
Retraining is required when:
|
||||||
|
- Significant document revisions occur
|
||||||
|
- Performance deficiencies identified
|
||||||
|
- Extended absence from job function
|
||||||
|
- Periodic requalification due
|
||||||
|
|
||||||
|
### 4.6 New Employee Orientation
|
||||||
|
|
||||||
|
All new employees shall complete:
|
||||||
|
1. Company orientation
|
||||||
|
2. Quality system overview
|
||||||
|
3. Job-specific training
|
||||||
|
4. SOP read and understand for applicable procedures
|
||||||
|
|
||||||
|
## 5. Training Records Retention
|
||||||
|
|
||||||
|
- Training records maintained for duration of employment
|
||||||
|
- Records retained 3 years after employee departure
|
||||||
|
- Records available for regulatory inspection
|
||||||
|
|
||||||
|
## 6. Related Documents
|
||||||
|
|
||||||
|
- FRM-004 Training Record Form
|
||||||
|
- FRM-005 Training Assessment Form
|
||||||
|
- Job Descriptions
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
136
SOPs/SOP-004-Internal-Audit.md
Normal file
136
SOPs/SOP-004-Internal-Audit.md
Normal file
@@ -0,0 +1,136 @@
|
|||||||
|
# Standard Operating Procedure: Internal Audit
|
||||||
|
|
||||||
|
| Document ID | SOP-004 |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | Internal Audit |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | Quality Assurance |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
This procedure covers:
|
||||||
|
- QMS process audits
|
||||||
|
- Compliance audits
|
||||||
|
- Product audits
|
||||||
|
- System audits
|
||||||
|
|
||||||
|
## 3. Definitions
|
||||||
|
|
||||||
|
| Term | Definition |
|
||||||
|
|------|------------|
|
||||||
|
| Audit | Systematic, independent examination to determine conformance |
|
||||||
|
| Auditor | Person qualified to perform audits |
|
||||||
|
| Finding | Observation of conformance or nonconformance |
|
||||||
|
| Observation | Noted item not rising to level of finding |
|
||||||
|
|
||||||
|
## 4. Responsibilities
|
||||||
|
|
||||||
|
### 4.1 Lead Auditor
|
||||||
|
- Plans and schedules audits
|
||||||
|
- Prepares audit checklists
|
||||||
|
- Conducts audit activities
|
||||||
|
- Reports audit findings
|
||||||
|
|
||||||
|
### 4.2 Quality Manager
|
||||||
|
- Maintains audit program
|
||||||
|
- Qualifies auditors
|
||||||
|
- Reviews audit reports
|
||||||
|
- Reports to management
|
||||||
|
|
||||||
|
### 4.3 Auditee
|
||||||
|
- Provides access to areas/records
|
||||||
|
- Responds to findings
|
||||||
|
- Implements corrective actions
|
||||||
|
|
||||||
|
## 5. Procedure
|
||||||
|
|
||||||
|
### 5.1 Annual Audit Schedule
|
||||||
|
|
||||||
|
1. Develop annual audit schedule considering:
|
||||||
|
- Previous audit results
|
||||||
|
- Process criticality
|
||||||
|
- Regulatory requirements
|
||||||
|
- Changes to processes
|
||||||
|
2. Ensure all QMS processes audited at least annually
|
||||||
|
3. Obtain management approval
|
||||||
|
4. Communicate schedule to affected areas
|
||||||
|
|
||||||
|
### 5.2 Auditor Qualification
|
||||||
|
|
||||||
|
Auditors shall:
|
||||||
|
- Complete auditor training course
|
||||||
|
- Conduct at least 2 audits under supervision
|
||||||
|
- Be independent of area being audited
|
||||||
|
- Maintain competence through ongoing audits
|
||||||
|
|
||||||
|
### 5.3 Audit Preparation
|
||||||
|
|
||||||
|
1. Review applicable procedures and standards
|
||||||
|
2. Review previous audit reports
|
||||||
|
3. Prepare audit checklist
|
||||||
|
4. Notify auditee of audit scope and schedule
|
||||||
|
5. Confirm auditor availability
|
||||||
|
|
||||||
|
### 5.4 Conducting the Audit
|
||||||
|
|
||||||
|
1. Hold opening meeting with auditee
|
||||||
|
2. Execute audit checklist
|
||||||
|
3. Gather objective evidence:
|
||||||
|
- Document review
|
||||||
|
- Personnel interviews
|
||||||
|
- Process observation
|
||||||
|
4. Document findings with evidence
|
||||||
|
5. Classify findings:
|
||||||
|
- Major Nonconformance
|
||||||
|
- Minor Nonconformance
|
||||||
|
- Observation
|
||||||
|
6. Hold closing meeting
|
||||||
|
|
||||||
|
### 5.5 Audit Reporting
|
||||||
|
|
||||||
|
1. Complete audit report within 5 business days
|
||||||
|
2. Report shall include:
|
||||||
|
- Audit scope and criteria
|
||||||
|
- Personnel interviewed
|
||||||
|
- Findings with evidence
|
||||||
|
- Recommendations
|
||||||
|
3. Distribute report to auditee and management
|
||||||
|
|
||||||
|
### 5.6 Finding Resolution
|
||||||
|
|
||||||
|
1. Auditee responds with corrective action plan within 10 business days
|
||||||
|
2. Quality reviews and approves plan
|
||||||
|
3. Auditee implements corrective actions
|
||||||
|
4. Auditor verifies effectiveness
|
||||||
|
5. Close finding upon verification
|
||||||
|
|
||||||
|
## 6. Audit Records
|
||||||
|
|
||||||
|
Maintain for 5 years:
|
||||||
|
- Audit schedules
|
||||||
|
- Checklists
|
||||||
|
- Reports
|
||||||
|
- Corrective action records
|
||||||
|
|
||||||
|
## 7. Related Documents
|
||||||
|
|
||||||
|
- FRM-006 Audit Checklist Template
|
||||||
|
- FRM-007 Audit Report Template
|
||||||
|
- SOP-002 CAPA
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
114
SOPs/SOP-005-Management-Review.md
Normal file
114
SOPs/SOP-005-Management-Review.md
Normal file
@@ -0,0 +1,114 @@
|
|||||||
|
# Standard Operating Procedure: Management Review
|
||||||
|
|
||||||
|
| Document ID | SOP-005 |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | Management Review |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | Quality Assurance |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
|
||||||
|
|
||||||
|
## 3. Frequency
|
||||||
|
|
||||||
|
Management reviews shall be conducted:
|
||||||
|
- At least annually
|
||||||
|
- More frequently if significant changes occur
|
||||||
|
- As needed based on quality performance
|
||||||
|
|
||||||
|
## 4. Responsibilities
|
||||||
|
|
||||||
|
### 4.1 Quality Manager
|
||||||
|
- Prepares management review agenda and materials
|
||||||
|
- Facilitates the meeting
|
||||||
|
- Documents meeting minutes and action items
|
||||||
|
- Tracks completion of action items
|
||||||
|
|
||||||
|
### 4.2 Top Management
|
||||||
|
- Attends management review meetings
|
||||||
|
- Reviews QMS performance data
|
||||||
|
- Makes decisions on QMS improvements
|
||||||
|
- Allocates resources as needed
|
||||||
|
|
||||||
|
### 4.3 Department Managers
|
||||||
|
- Provides input data for their areas
|
||||||
|
- Attends management review
|
||||||
|
- Implements assigned action items
|
||||||
|
|
||||||
|
## 5. Management Review Inputs
|
||||||
|
|
||||||
|
The following shall be considered:
|
||||||
|
|
||||||
|
### 5.1 Actions from Previous Reviews
|
||||||
|
- Status of action items
|
||||||
|
- Effectiveness of implemented actions
|
||||||
|
|
||||||
|
### 5.2 Changes in Context
|
||||||
|
- Internal changes (organization, resources)
|
||||||
|
- External changes (regulations, market)
|
||||||
|
|
||||||
|
### 5.3 QMS Performance
|
||||||
|
- Customer satisfaction and feedback
|
||||||
|
- Quality objectives achievement
|
||||||
|
- Process performance metrics
|
||||||
|
- Nonconformities and corrective actions
|
||||||
|
- Audit results
|
||||||
|
- Supplier performance
|
||||||
|
|
||||||
|
### 5.4 Resource Adequacy
|
||||||
|
- Personnel
|
||||||
|
- Infrastructure
|
||||||
|
- Work environment
|
||||||
|
|
||||||
|
### 5.5 Risk and Opportunities
|
||||||
|
- Risk assessment results
|
||||||
|
- Effectiveness of risk controls
|
||||||
|
- New opportunities identified
|
||||||
|
|
||||||
|
### 5.6 Improvement Opportunities
|
||||||
|
- Process improvements
|
||||||
|
- Product improvements
|
||||||
|
- QMS enhancements
|
||||||
|
|
||||||
|
## 6. Management Review Outputs
|
||||||
|
|
||||||
|
Decisions and actions related to:
|
||||||
|
- Improvement of QMS and processes
|
||||||
|
- Product improvement
|
||||||
|
- Resource needs
|
||||||
|
- Changes to quality policy or objectives
|
||||||
|
|
||||||
|
## 7. Documentation
|
||||||
|
|
||||||
|
### 7.1 Meeting Minutes
|
||||||
|
- Date and attendees
|
||||||
|
- Items discussed
|
||||||
|
- Decisions made
|
||||||
|
- Action items with owners and due dates
|
||||||
|
|
||||||
|
### 7.2 Record Retention
|
||||||
|
- Management review records retained for 5 years
|
||||||
|
- Available for regulatory inspection
|
||||||
|
|
||||||
|
## 8. Related Documents
|
||||||
|
|
||||||
|
- FRM-008 Management Review Agenda Template
|
||||||
|
- FRM-009 Management Review Minutes Template
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
1
SOPs/Safety/.gitkeep
Normal file
1
SOPs/Safety/.gitkeep
Normal file
@@ -0,0 +1 @@
|
|||||||
|
# Placeholder
|
||||||
62
Templates/SOP-Template.md
Normal file
62
Templates/SOP-Template.md
Normal file
@@ -0,0 +1,62 @@
|
|||||||
|
# Standard Operating Procedure: [Title]
|
||||||
|
|
||||||
|
| Document ID | SOP-XXX |
|
||||||
|
|-------------|---------|
|
||||||
|
| Title | [Title] |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | [DEPARTMENT] |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
[State the purpose of this procedure]
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
[Define the scope and applicability]
|
||||||
|
|
||||||
|
## 3. Responsibilities
|
||||||
|
|
||||||
|
### 3.1 [Role 1]
|
||||||
|
- [Responsibility]
|
||||||
|
- [Responsibility]
|
||||||
|
|
||||||
|
### 3.2 [Role 2]
|
||||||
|
- [Responsibility]
|
||||||
|
- [Responsibility]
|
||||||
|
|
||||||
|
## 4. Definitions
|
||||||
|
|
||||||
|
| Term | Definition |
|
||||||
|
|------|------------|
|
||||||
|
| | |
|
||||||
|
|
||||||
|
## 5. Procedure
|
||||||
|
|
||||||
|
### 5.1 [Section Title]
|
||||||
|
|
||||||
|
[Procedure steps]
|
||||||
|
|
||||||
|
### 5.2 [Section Title]
|
||||||
|
|
||||||
|
[Procedure steps]
|
||||||
|
|
||||||
|
## 6. Related Documents
|
||||||
|
|
||||||
|
- [List related procedures, forms, etc.]
|
||||||
|
|
||||||
|
## 7. References
|
||||||
|
|
||||||
|
- [External standards, regulations, etc.]
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
68
Work Instructions/WI-001-Template.md
Normal file
68
Work Instructions/WI-001-Template.md
Normal file
@@ -0,0 +1,68 @@
|
|||||||
|
# Work Instruction: [Title]
|
||||||
|
|
||||||
|
| Document ID | WI-001 |
|
||||||
|
|-------------|--------|
|
||||||
|
| Title | [Title] |
|
||||||
|
| Revision | 1.0 |
|
||||||
|
| Effective Date | [DATE] |
|
||||||
|
| Author | [AUTHOR] |
|
||||||
|
| Approved By | [APPROVER] |
|
||||||
|
| Department | [DEPARTMENT] |
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## 1. Purpose
|
||||||
|
|
||||||
|
[Describe the purpose of this work instruction]
|
||||||
|
|
||||||
|
## 2. Scope
|
||||||
|
|
||||||
|
[Define what activities this instruction covers]
|
||||||
|
|
||||||
|
## 3. Safety Precautions
|
||||||
|
|
||||||
|
- [List any safety requirements]
|
||||||
|
- [Personal protective equipment needed]
|
||||||
|
- [Hazards to be aware of]
|
||||||
|
|
||||||
|
## 4. Equipment/Materials Required
|
||||||
|
|
||||||
|
| Item | Specification |
|
||||||
|
|------|---------------|
|
||||||
|
| | |
|
||||||
|
| | |
|
||||||
|
|
||||||
|
## 5. Procedure
|
||||||
|
|
||||||
|
### Step 1: [Title]
|
||||||
|
[Detailed instructions]
|
||||||
|
|
||||||
|
### Step 2: [Title]
|
||||||
|
[Detailed instructions]
|
||||||
|
|
||||||
|
### Step 3: [Title]
|
||||||
|
[Detailed instructions]
|
||||||
|
|
||||||
|
## 6. Acceptance Criteria
|
||||||
|
|
||||||
|
[Define what constitutes successful completion]
|
||||||
|
|
||||||
|
## 7. Records
|
||||||
|
|
||||||
|
| Record | Location | Retention |
|
||||||
|
|--------|----------|-----------|
|
||||||
|
| | | |
|
||||||
|
|
||||||
|
## 8. References
|
||||||
|
|
||||||
|
- [Related SOPs]
|
||||||
|
- [Specifications]
|
||||||
|
- [Standards]
|
||||||
|
|
||||||
|
---
|
||||||
|
|
||||||
|
## Revision History
|
||||||
|
|
||||||
|
| Rev | Date | Description | Author |
|
||||||
|
|-----|------|-------------|--------|
|
||||||
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||||
Reference in New Lab Ticket
Block a user