A comprehensive checklist for ensuring compliance of Electronic Batch Record (eBR) systems with FDA 21 CFR Part 11 in pharmaceutical manufacturing, covering system functionality, data integrity, and regulatory requirements.
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About This Checklist
The Pharmaceutical Electronic Batch Record (eBR) Compliance Checklist is a vital tool for ensuring that electronic batch records in pharmaceutical manufacturing adhere to FDA 21 CFR Part 11 regulations. This comprehensive checklist guides companies through the intricate process of implementing and maintaining compliant eBR systems, which are crucial for documenting the production and quality control of drug products. By addressing key aspects such as system functionality, data integrity, audit trails, and electronic signatures, this checklist helps pharmaceutical manufacturers streamline their production processes while maintaining regulatory compliance and product quality.
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FAQs
The checklist covers components such as user access controls, electronic signatures, audit trails, data entry validation, record review processes, and system integration with other manufacturing equipment.
It includes specific sections on data input validation, change control procedures, data backup and recovery, and mechanisms to prevent unauthorized alterations to electronic records.
Yes, the checklist is designed for both new eBR system implementations and for assessing the compliance of existing electronic batch record systems.
It includes sections on system integration, data transfer validation, and compatibility checks with other GMP-critical systems like LIMS, MES, and ERP systems.
The checklist covers electronic signature creation, validation, linking to respective records, non-repudiation, and compliance with 21 CFR Part 11 requirements for e-signatures.
Benefits of Pharmaceutical Electronic Batch Record (eBR) Compliance Checklist
Ensures eBR systems comply with FDA 21 CFR Part 11 requirements
Improves accuracy and completeness of batch production records
Enhances traceability and reduces time for batch release
Facilitates easier regulatory inspections and audits of manufacturing processes
Supports continuous improvement in pharmaceutical manufacturing operations