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Pharmaceutical Computer System Validation Checklist

A comprehensive checklist for validating computer systems in pharmaceutical companies to ensure compliance with FDA 21 CFR Part 11, covering all aspects from system development to maintenance.

Pharmaceutical Computer System Validation Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Computer System Validation Checklist is an indispensable tool for ensuring that computerized systems used in drug manufacturing and quality control meet FDA 21 CFR Part 11 requirements. This comprehensive checklist guides pharmaceutical companies through the complex process of validating computer systems, from initial risk assessment to ongoing maintenance. By systematically addressing software development, hardware qualification, and system performance, this checklist helps maintain data integrity, enhance product quality, and streamline regulatory compliance in the increasingly digital pharmaceutical landscape.

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Industry

Pharmaceuticals

Standard

FDA 21 CFR Part 11

Workspaces

Pharmaceutical IT Departments and Manufacturing Facilities

Occupations

IT Validation Specialist
Quality Assurance Engineer
Computer Systems Auditor
Regulatory Compliance Officer
Pharmaceutical Process Engineer

Computer System Validation Questions

(0 / 4)

1
Have any data integrity issues been identified in the system?

Describe any data integrity issues found.

To ensure that the integrity of the data is maintained and any issues are documented.
2
What is the current compliance maturity level of the computerized system?

Select the compliance maturity level.

To assess the compliance maturity of the system in relation to regulatory standards.
3
What is the version number of the validation protocol used?

Enter the version number of the validation protocol.

To confirm that the most recent protocols are being followed.
Min: 1
Target: 1.0
Max: 5
4
Is the computer system properly qualified as per GxP compliance requirements?

Select the qualification status of the system.

To ensure that the system meets regulatory standards for qualification.
5
When was the last validation conducted for the software?

Select the date of the last validation.

To track the frequency of validations and ensure compliance.
6
What is the risk assessment score assigned to the software?

Enter the risk assessment score (1-5).

To evaluate the risk associated with the software based on its usage.
Min: 1
Target: 2
Max: 5
7
Provide a summary of the validation process conducted for the software.

Summarize the validation process here.

To have a documented overview of the validation process for reference.
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8
Is the software validated according to FDA 21 CFR Part 11 requirements?

Select the validation status of the software.

To ensure compliance with software validation standards.
9
When was the last compliance review of the computerized system conducted?

Select the date of the last compliance review.

To track the timeliness of compliance reviews.
10
Are training records for users of the computerized system up to date?

Describe the status of training records.

To ensure that all users have received proper training on system usage.
11
Is the audit trail functionality of the system active and properly configured?

Select the status of the audit trail functionality.

To verify that all system activities are logged for compliance purposes.
12
Is there an access control policy implemented for the computerized system?

Indicate if the access control policy is implemented.

To ensure that only authorized personnel have access to the system.
13
When is the change scheduled to be implemented?

Select the implementation date of the change.

To ensure that there is a clear timeline for the implementation of changes.
14
Provide a detailed description of the change being implemented.

Describe the change in detail.

To document the specifics of the change for future reference.
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15
What is the identification number of the change request?

Enter the change request ID.

To track and reference specific change requests for accountability.
Min: 1
Target: 12345
Max: 99999
16
Has the software change been approved by the relevant stakeholders?

Select the approval status of the change.

To ensure that all changes to the software are reviewed and approved.
17
How many security incidents have been reported in the last year?

Enter the number of reported security incidents.

To assess the effectiveness of data security measures.
Min: 0
Target: 0
Max: 100
18
When was the last review of data access permissions conducted?

Describe the date and findings of the last access review.

To ensure that access to sensitive data is restricted to authorized personnel only.
19
Is there an incident response plan in place for data breaches?

Select the status of the incident response plan.

To verify that procedures are established for responding to data security incidents.
20
Is sensitive data encrypted both at rest and in transit?

Indicate if data encryption is implemented.

To ensure that sensitive information is protected from unauthorized access.

FAQs

The checklist covers all phases including planning, specification, design, development, testing, implementation, and maintenance of computerized systems.

It includes specific sections for validating cloud-based and SaaS applications, focusing on data security, access controls, and vendor qualifications.

The checklist requires documentation such as validation plans, user requirements, functional specifications, risk assessments, test protocols, and validation reports.

The checklist recommends periodic revalidation based on risk assessment, typically annually or after significant system changes or upgrades.

Yes, the checklist includes sections for retrospective validation of legacy systems, ensuring they meet current regulatory requirements.

Benefits

Ensures compliance with FDA 21 CFR Part 11 for computerized systems

Reduces risks associated with computer system failures or data integrity issues

Improves efficiency in the validation process

Facilitates consistent and standardized approach to system validation

Supports easier regulatory inspections and audits of computerized systems