PHARMACEUTICAL BOM TRACEABILITY CHECKLIST

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--- COMPONENT IDENTIFICATION & SOURCING ---
[ ] Component Part Number
[ ] Component Description
[ ] Component Classification (e.g., Raw Material, Sub-Assembly) (Raw Material, Sub-Assembly, Finished Good, Hardware, Software)
[ ] Supplier Status (Approved, Pending Approval, Unapproved) (Approved, Pending Approval, Unapproved)
[ ] Supplier Part Number
[ ] Supplier Name
[ ] Quantity per BOM
[ ] Supplier Data Sheet (Optional)

--- LOT & SERIAL NUMBER TRACKING ---
[ ] Component Lot Number
[ ] Component Serial Number (if applicable)
[ ] Quantity Received
[ ] Date of Receipt
[ ] Receiving Notes/Observations
[ ] Supplier Lot Number
[ ] Lot Status (Verified, Pending Verification, Rejected)
[ ] Supporting Documentation (e.g., Receiving Record)

--- SUPPLIER QUALIFICATION & AUDITS ---
[ ] Supplier Qualification Status (Approved, Pending Approval, Suspended, Rejected)
[ ] Initial Qualification Date
[ ] Last Audit Date
[ ] Audit Score (e.g., 1-100)
[ ] Key Findings from Last Audit
[ ] Audit Report (PDF)
[ ] Corrective Action Plan Status (Open, In Progress, Closed)
[ ] Summary of Supplier CAPA (Corrective Action Preventive Action)

--- MATERIAL CERTIFICATES & TESTING ---
[ ] Certificate of Analysis (CoA) - Primary Material
[ ] Certificate of Analysis (CoA) - Secondary Material (if applicable)
[ ] CoA Revision Number
[ ] CoA Issue Date
[ ] Summary of Testing Parameters (per CoA)
[ ] Testing Performed (Select all that apply) (Chemical Analysis, Physical Testing, Microbial Testing, Particle Size Analysis, Other (Specify in Long Text))
[ ] Specify 'Other' Testing (if selected above)
[ ] Result Threshold/Specification Limit
[ ] CoA Status (Valid, Expired, Invalid)

--- CHANGE CONTROL & APPROVALS ---
[ ] Date of Change Request
[ ] Description of Change
[ ] Change Category (e.g., Component, Supplier, Specification) (Component, Supplier, Specification, Process, Other)
[ ] Revision Number (Pre-Change)
[ ] Revision Number (Post-Change)
[ ] Affected BOM(s)
[ ] Requestor Signature
[ ] Reason for Change

--- DOCUMENTATION & RECORD KEEPING ---
[ ] Document Creation Date
[ ] Last Review Date
[ ] Summary of Record Keeping Procedures
[ ] Number of Copies Maintained
[ ] Record Storage Location (Electronic, Physical (Designated Room), Hybrid)
[ ] Sample Record Documentation (e.g., CoA, Supplier Audit Report)
[ ] Record Keeper Signature
[ ] Time of Record Update

--- DEVIATION REPORTING & INVESTIGATION ---
[ ] Description of Deviation
[ ] Date of Deviation
[ ] Time of Deviation
[ ] Deviation Category (e.g., Material, Process, Documentation) (Material, Process, Documentation, Equipment, Other)
[ ] Quantity Affected (if applicable)
[ ] Related Components/Materials Affected (Select all that apply)
[ ] Root Cause Analysis Findings
[ ] Corrective Actions Taken
[ ] Date Corrective Actions Implemented
[ ] Signature of Investigator

--- REGULATORY COMPLIANCE & VALIDATION ---
[ ] Applicable Regulations (e.g., FDA 21 CFR Part 11, EU GMP) (FDA 21 CFR Part 11, EU GMP, Other (Specify in Long Text))
[ ] Specification of 'Other' Regulations (If Selected Above)
[ ] Date of Last Regulatory Audit
[ ] Audit Score (if applicable)
[ ] Summary of Audit Findings and Corrective Actions
[ ] Copy of Latest Regulatory Audit Report
[ ] Validation Status of Traceability System (Validated, In Validation, Not Validated)
[ ] Date of Last Validation/Revalidation

--- TRAINING & COMPETENCY ---
[ ] Number of Employees Trained on BOM Traceability
[ ] Training Delivery Method (e.g., Classroom, Online, Hybrid) (Classroom, Online, Hybrid)
[ ] Date of Last Training Refresher
[ ] Brief Description of Training Curriculum
[ ] Level of Training Certification Required (if applicable) (None, Level 1, Level 2, Level 3)
[ ] Upload Training Records/Certificates (optional)

--- SYSTEM INTEGRATION & DATA INTEGRITY ---
[ ] Number of Integrated Systems
[ ] Data Synchronization Method (Real-time, Batch, Manual)
[ ] Last Data Integrity Audit Date
[ ] Description of Data Validation Checks Performed
[ ] Data Backup Frequency (Daily, Weekly, Monthly)
[ ] Data Flow Diagrams (if applicable)
[ ] Number of Data Breaches/Integrity Incidents (past year)

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