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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?

Select compliance status.

To ensure that the eBR system meets regulatory requirements for electronic records.
2
Are there established procedures to ensure data integrity in the eBR system?

Indicate whether procedures are established.

To verify that data integrity measures are in place as required by regulatory standards.
3
What is the frequency of audit trail reviews for the eBR system?

Enter frequency in months.

To assess the regular monitoring of audit trails to ensure compliance.
Min: 1
Target: Monthly
Max: 12
4
Are electronic signatures verified and validated according to established procedures?

Select verification status.

To confirm that electronic signatures comply with FDA regulations.
5
Provide details of the latest batch production records review.

Enter details of the review.

To gather insights and evidence of compliance in batch production processes.
6
When was the last compliance audit conducted on the eBR system?

Select the date of the last compliance audit.

To track the audit history for compliance verification.

7
Are there established data backup procedures for the eBR system?

Select backup procedure status.

To ensure that data integrity is maintained through regular backups.
8
What is the average error rate for data entry in the eBR system?

Enter the average error rate (percentage).

To evaluate data entry quality and identify areas for improvement.
9
Is there a change control process in place for modifications to the eBR system?

Indicate whether a change control process exists.

To confirm that any changes to the system are documented and controlled.
10
How often does the eBR system experience downtime?

Enter frequency of downtime incidents (per month).

To assess the reliability and availability of the eBR system.
Min: 0
Target: 0
Max: 100
11
Provide a summary of user feedback regarding the eBR system.

Enter summary of user feedback.

To gather insights into user experiences and identify potential areas for enhancement.
12
When was the last audit conducted on the eBR system?

Select the date of the last system audit.

To track the audit history and ensure regular evaluations are performed.

13
Is there a regular system performance monitoring process for the eBR system?

Select monitoring process status.

To ensure that the system is functioning as expected and to identify any performance issues.
14
What is the average response time for the eBR system?

Enter average response time in seconds.

To assess the efficiency of the system in processing requests.
Min: 0
Target: 1
15
Are there established procedures for incident management related to the eBR system?

Indicate whether incident management procedures are established.

To verify that incidents are managed effectively to minimize downtime.
16
Describe any operational challenges faced with the eBR system.

Enter description of operational challenges.

To identify and address challenges impacting system performance.
17
When was the last performance evaluation conducted on the eBR system?

Select the date of the last performance evaluation.

To track the history of performance evaluations and ensure regular assessments.

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

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