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GMP Computerized Systems Validation Audit Checklist

A specialized audit checklist for evaluating GMP compliance in pharmaceutical computerized systems validation, ensuring data integrity, system reliability, and regulatory compliance in electronic records management.

GMP Computerized Systems Validation Audit Checklist
by: audit-now
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About This Checklist

In the modern pharmaceutical industry, computerized systems play a crucial role in managing manufacturing processes, quality control, and data management. This GMP Computerized Systems Validation Audit Checklist is an essential tool for evaluating compliance with Good Manufacturing Practice (GMP) standards in the implementation, validation, and maintenance of computerized systems. It addresses critical aspects such as system lifecycle management, data integrity, access controls, and change management specific to computerized systems. By systematically assessing these areas, pharmaceutical companies can ensure the reliability and accuracy of their computerized systems, maintain data integrity, and comply with regulatory requirements for electronic records and signatures.

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Industry

Pharmaceuticals

Standard

Good Manufacturing Practice (GMP)

Workspaces

Pharmaceutical Manufacturing and Quality Control IT Environments

Occupations

IT Validation Specialist
Quality Assurance Manager
Computer System Validation Engineer
GMP Auditor
Regulatory Compliance Officer

Computerized Systems Validation and Management

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1
What is the frequency of audit trail reviews?

Enter the number of days between reviews.

Regular reviews help in identifying any discrepancies in records.
Min: 1
Target: 30
Max: 90
2
Describe the change control procedures for the computerized system.

Provide a detailed description.

Proper change control is essential for maintaining system integrity.
3
Is there a process in place to ensure data integrity?

Please confirm if there is a data integrity assurance process.

Data integrity is critical for compliance and quality assurance.
4
Is the computerized system compliant with GMP regulations?

Select the compliance status.

Ensures adherence to industry standards for manufacturing practices.
5
What was the date of the last software review?

Select the date of the last review.

Tracking review dates ensures regular evaluations are conducted.
6
What is the risk assessment score for the software?

Enter the risk assessment score.

Understanding risk levels is vital for compliance and management.
Min: 1
Target: 2
Max: 5
7
Provide the validation documentation for the software.

Attach or describe the validation documentation.

Validation documentation is essential for regulatory compliance.
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8
Is the software in compliance with the defined lifecycle stages?

Select the compliance status based on the current lifecycle stage.

Ensures that the software is managed according to lifecycle management principles.
9
What is the average incident response time for data integrity issues?

Enter the average response time in hours.

Quick response to data integrity incidents is crucial for maintaining quality.
Min: 1
Target: 24
Max: 72
10
Describe the training provided to employees regarding data integrity.

Provide a detailed description of the training program.

Training ensures that employees understand the importance of data integrity.
11
Are there access controls in place to protect data integrity?

Confirm if access controls are implemented.

Access controls are essential to prevent unauthorized access to sensitive data.
12
Is there a documented process for data backup and recovery?

Select the backup status of the data management system.

Data backup is critical for ensuring data integrity and availability.
13
How often does the system experience downtime affecting electronic records?

Enter the average number of downtimes per month.

Monitoring system downtime is important for ensuring availability and reliability.
Min: 0
Target: 2
Max: 10
14
Describe the policies for user access management in the electronic records system.

Provide a detailed description of the user access management policies.

Robust access management policies are essential to protect electronic records.
15
Does the system have an adequate audit trail functionality?

Confirm if audit trail functionality is implemented.

Audit trails are crucial for tracking changes and ensuring accountability.
16
Are electronic records maintained in compliance with 21 CFR Part 11?

Select the compliance status of the electronic records.

Compliance with 21 CFR Part 11 is essential for electronic records to be considered valid.
17
What is the risk acceptance threshold for the organization?

Enter the risk acceptance threshold score.

Understanding the risk acceptance threshold is crucial for decision-making.
Min: 1
Target: 5
Max: 10
18
Provide documentation of the risk mitigation strategies in place.

Attach or describe the mitigation strategies.

Documented strategies are essential for effective risk management.
19
Are risk assessments reviewed on a regular basis?

Confirm if regular risk reviews are conducted.

Regular reviews help to identify new risks and mitigate existing ones.
20
Are there established procedures for conducting risk assessments?

Select the status of risk assessment procedures.

Clear procedures ensure consistent and thorough risk assessments.

FAQs

The checklist covers system development lifecycle, validation documentation, user requirements, functional specifications, risk assessments, testing protocols, data integrity controls, and system maintenance procedures.

It includes specific items to verify implementation of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) in electronic records management.

Yes, the checklist is designed to audit validation processes for both custom-developed software and commercial off-the-shelf (COTS) systems, with sections addressing the specific requirements for each type.

It's recommended to conduct a comprehensive audit annually, with more frequent reviews when implementing new systems or making significant changes to existing ones.

The audit team should typically include IT specialists, quality assurance personnel, validation experts, and end-users or process owners of the systems being audited.

Benefits

Ensures comprehensive evaluation of computerized systems used in GMP-regulated environments

Helps identify and mitigate risks associated with computerized system failures or data integrity issues

Supports compliance with 21 CFR Part 11 and other relevant regulations for electronic records

Enhances overall data reliability and system performance in pharmaceutical operations

Facilitates continuous improvement in computerized system management and validation practices