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Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist

A comprehensive checklist for auditing pharmaceutical Laboratory Information Management Systems (LIMS), covering data integrity, system validation, access controls, and electronic records management to ensure compliance with regulatory requirements and maintain data reliability.

Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist is a crucial tool for ensuring the integrity, security, and compliance of laboratory data management processes in pharmaceutical companies. This comprehensive checklist addresses key aspects of LIMS implementation and operation, including data integrity, system validation, user access controls, audit trails, and electronic records management. By systematically evaluating LIMS processes, pharmaceutical companies can maintain compliance with regulatory requirements such as 21 CFR Part 11, enhance the reliability of laboratory data, and streamline laboratory operations. This checklist helps identify potential vulnerabilities in data management practices, ultimately contributing to the overall quality and trustworthiness of pharmaceutical research and quality control processes.

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Industry

Pharmaceuticals

Standard

21 CFR Part 11 (Electronic Records; Electronic Signatures) and EU GMP Annex 11 (Computerised Systems)

Workspaces

Pharmaceutical Laboratories and IT Departments

Occupations

IT Manager
Quality Assurance Specialist
Laboratory Manager
LIMS Administrator
Data Integrity Auditor

LIMS Data Integrity Checks

(0 / 5)

1
Are electronic records being maintained in compliance with 21 CFR Part 11?

Select the compliance status.

To assess the adherence of electronic record-keeping practices to regulatory standards.
2
When was the last system validation performed?

Select the date of the last validation.

To verify that the system is regularly validated as per compliance requirements.
3
How often are data backups performed?

Enter the frequency in days.

To assess the risk of data loss and ensure compliance with data retention policies.
Min: 1
Target: Daily
Max: 30
4
Have all relevant personnel received training on data integrity?

Indicate whether training has been completed.

To confirm that all staff are knowledgeable about data integrity principles.
5
Is the audit trail function enabled and working correctly?

Select the compliance status.

To ensure that all changes in the system are logged for traceability.
6
When was the last security audit conducted?

Select the date of the last security audit.

To verify that security measures are being regularly evaluated.
7
What is the maximum number of failed login attempts allowed?

Enter the maximum number of allowed failed attempts.

To ensure proper security measures are in place to prevent unauthorized access.
Min: 1
Target: 5
Max: 10
8
Is there a documented access control policy?

Provide details about the access control policy.

To confirm that there are defined rules and guidelines for access control.
9
Is two-factor authentication implemented for all user accounts?

Indicate whether two-factor authentication is in use.

To ensure an additional layer of security for accessing sensitive data.
10
How frequently are user access rights reviewed?

Select the review frequency.

To ensure that access rights are kept up-to-date to minimize security risks.
11
When is the next scheduled compliance review?

Select the date for the next compliance review.

To ensure that compliance reviews are planned and conducted in a timely manner.
12
How many compliance audits have been conducted in the past year?

Enter the total number of compliance audits.

To assess the frequency of compliance evaluations and identify potential areas for improvement.
Min: 0
Target: 4
Max: 12
13
Are all compliance-related documents readily available?

Provide details about the availability of compliance documents.

To confirm that necessary documentation for compliance is accessible when needed.
14
Are staff members required to undergo periodic compliance training?

Indicate whether periodic compliance training is mandatory.

To ensure all personnel are regularly updated on compliance requirements.
15
Is the LIMS compliant with relevant regulatory requirements?

Select the compliance status.

To assess adherence to regulations that govern laboratory information management.

FAQs

The checklist covers various aspects including system validation, data integrity controls, user management and access controls, audit trail functionality, electronic signatures, data backup and recovery, and system integration with laboratory instruments.

By ensuring robust LIMS processes and controls, this checklist helps maintain the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) for data integrity throughout the laboratory data lifecycle.

This checklist is designed for use by IT managers, quality assurance specialists, laboratory managers, and internal auditors in pharmaceutical companies, as well as external auditors and regulatory inspectors focused on computerized systems.

LIMS audits should be conducted periodically, typically annually, and also after any significant system upgrades or changes. Additionally, ongoing monitoring and periodic reviews of system performance and compliance should be performed.

Yes, the checklist can be adapted for various types of pharmaceutical laboratories including quality control, research and development, and stability testing laboratories, ensuring comprehensive coverage across different laboratory environments and their specific LIMS requirements.

Benefits

Ensures compliance with data integrity regulations and GxP requirements

Improves the reliability and traceability of laboratory data

Enhances laboratory efficiency and reduces manual errors

Facilitates regulatory inspections and audits related to computerized systems

Strengthens data security and confidentiality measures