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Pharmaceutical Electronic Batch Record (eBR) Compliance Checklist

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.

Pharmaceutical Electronic Batch Record (eBR) Compliance Checklist

by: audit-now
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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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Industry

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Manufacturing Process Engineer
Quality Assurance Specialist
IT Systems Validator
Regulatory Compliance Manager
Production Supervisor
1
Is the electronic batch record system compliant with FDA 21 CFR Part 11?
2
Are there established procedures to ensure data integrity in the eBR system?
3
What is the frequency of audit trail reviews for the eBR system?
Min: 1
Target: Monthly
Max: 12
4
Are electronic signatures verified and validated according to established procedures?
5
Provide details of the latest batch production records review.
6
When was the last compliance audit conducted on the eBR system?
7
Are there established data backup procedures for the eBR system?
8
What is the average error rate for data entry in the eBR system?
9
Is there a change control process in place for modifications to the eBR system?
10
How often does the eBR system experience downtime?
Min: 0
Target: 0
Max: 100
11
Provide a summary of user feedback regarding the eBR system.
12
When was the last audit conducted on the eBR system?
13
Is there a regular system performance monitoring process for the eBR system?
14
What is the average response time for the eBR system?
Min: 0
Target: 1
15
Are there established procedures for incident management related to the eBR system?
16
Describe any operational challenges faced with the eBR system.
17
When was the last performance evaluation conducted on the eBR system?

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