Data Integrity Assessment ALCOA+ Principles Checklist [FREE PDF]
This data integrity assessment alcoa+ principles checklist ensures compliance with FDA Data Integrity Guidance 2018 requirements. Data Integrity Officer / QAs use this checklist to verify regulatory compliance, document findings, and maintain safety and quality standards.
- Industry: Pharmaceutical / Life Sciences
- Frequency: Quarterly
- Estimated Time: 3-4 hours
- Role: Data Integrity Officer / QA
- Total Items: 21
- Compliance: FDA Data Integrity Guidance 2018, MHRA Data Integrity Guidance, WHO Technical Report Series 996, ICH Q10 Pharmaceutical Quality System
Documentation and Regulatory Review
Verify required documentation is current and complete.
- Standard Operating Procedures (SOPs) current and accessible?
- All personnel training records current for this activity?
- Required permits, licenses, and registrations current?
- Previous inspection findings reviewed and corrective actions verified?
Safety and Equipment Requirements
Verify safety equipment, PPE, and emergency preparations.
- Required PPE available, clean, and in good condition?
- Emergency equipment (eyewash, shower, extinguisher) accessible?
- Safety Data Sheets (SDS) available for all hazardous materials?
- Emergency contact and response procedures posted?
Operational Compliance Checks
Verify operations comply with regulatory requirements.
- Approved procedures being followed without deviation?
- Equipment qualified/calibrated and within calibration period?
- Environmental monitoring (temp, humidity, pressure) within spec?
- All materials, products, and containers properly labeled?
- Data recorded contemporaneously with no unexplained alterations?
Waste Disposal and Environmental Compliance
Verify proper waste handling and disposal.
- All waste properly labeled with contents and hazard class?
- Waste containers appropriate for waste type and in good condition?
- Waste streams segregated per regulatory requirements?
- Waste disposal records maintained?
Findings and CAPA
Document findings and corrective/preventive actions.
- Any deviations or non-conformances identified?
- CAPA initiated for any findings?
- Photo documentation of findings?
- Inspection findings and recommendations
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Why Use This Data Integrity Assessment ALCOA+ Principles Checklist [FREE PDF]?
This data integrity assessment alcoa+ principles checklist [free pdf] helps pharmaceutical / life sciences teams maintain compliance and operational excellence. Designed for data integrity officer / qa professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with FDA Data Integrity Guidance 2018, MHRA Data Integrity Guidance, WHO Technical Report Series 996, ICH Q10 Pharmaceutical Quality System. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Data Integrity Assessment ALCOA+ Principles Checklist [FREE PDF] cover?
This checklist covers 21 inspection items across 5 sections: Documentation and Regulatory Review, Safety and Equipment Requirements, Operational Compliance Checks, Waste Disposal and Environmental Compliance, Findings and CAPA. It is designed for pharmaceutical / life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 3-4 hours.
Who should use this Data Integrity Assessment ALCOA+ Principles Checklist [FREE PDF]?
This checklist is designed for Data Integrity Officer / QA professionals in the pharmaceutical / life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.