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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

Healthcare

Standard

Good Manufacturing Practices (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
1
Is the computerized system compliant with GMP regulations?
2
Is there a process in place to ensure data integrity?
3
Describe the change control procedures for the computerized system.
4
What is the frequency of audit trail reviews?
Min: 1
Target: 30
Max: 90
5
Is the software in compliance with the defined lifecycle stages?
6
Provide the validation documentation for the software.
7
What is the risk assessment score for the software?
Min: 1
Target: 2
Max: 5
8
What was the date of the last software review?
9
Is there a documented process for data backup and recovery?
10
Are there access controls in place to protect data integrity?
11
Describe the training provided to employees regarding data integrity.
12
What is the average incident response time for data integrity issues?
Min: 1
Target: 24
Max: 72
13
Are electronic records maintained in compliance with 21 CFR Part 11?
14
Does the system have an adequate audit trail functionality?
15
Describe the policies for user access management in the electronic records system.
16
How often does the system experience downtime affecting electronic records?
Min: 0
Target: 2
Max: 10
17
Are there established procedures for conducting risk assessments?
18
Are risk assessments reviewed on a regular basis?
19
Provide documentation of the risk mitigation strategies in place.
20
What is the risk acceptance threshold for the organization?
Min: 1
Target: 5
Max: 10

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 of GMP Computerized Systems Validation Audit Checklist

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