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Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist

A comprehensive checklist for ensuring compliance of Laboratory Information Management Systems (LIMS) with FDA 21 CFR Part 11 in pharmaceutical quality control laboratories, covering system functionality, data integrity, and regulatory requirements.

Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist

by: audit-now
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About This Checklist

The Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist is an essential tool for ensuring that LIMS used in pharmaceutical quality control laboratories meet FDA 21 CFR Part 11 requirements. This comprehensive checklist guides pharmaceutical companies through the complex process of implementing, validating, and maintaining compliant LIMS. By addressing key aspects such as data integrity, system security, audit trails, and integration with laboratory instruments, this checklist helps maintain the highest standards of laboratory operations, enhances the reliability of analytical results, and ensures regulatory compliance in pharmaceutical quality control processes.

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Industry

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Facilities

Occupations

Laboratory Manager
Quality Control Analyst
LIMS Administrator
Compliance Specialist
Analytical Chemist
1
Is there a documented procedure for granting and revoking access to the LIMS?
2
How often are the audit trails of the LIMS reviewed?
3
Are data integrity checks performed regularly on the LIMS?
4
What is the total system downtime in the past month (in hours)?
Min: 0
Target: 0
Max: 168
5
Is the LIMS compliant with FDA 21 CFR Part 11 requirements?
6
Are electronic records protected with appropriate security measures?
7
Describe the data backup procedures in place for the LIMS.
8
What is the percentage of data entry errors in the LIMS over the last quarter?
Min: 0
Target: 0
Max: 100
9
When was the LIMS last updated?
10
Have all users received training on the LIMS functionalities?
11
What is the average response time of the LIMS system (in seconds)?
Min: 0
Target: 2
Max: 10
12
Is the LIMS integrated with laboratory instruments for data collection?
13
Is there a regular maintenance schedule for the LIMS?
14
Provide feedback collected from users regarding the usability of the LIMS.
15
When is the next scheduled audit for the LIMS?
16
What is the assessed risk level of a data breach occurring in the LIMS?
17
What is the average response time to incidents reported in the LIMS (in minutes)?
Min: 0
Target: 5
Max: 60
18
Are there established procedures for reporting incidents in the LIMS?
19
Describe the strategies in place to mitigate risks associated with the LIMS.
20
When was the last risk assessment conducted for the LIMS?
21
Are quality control procedures documented and followed in the LIMS?
22
What is the total number of deviation reports generated in the last year?
Min: 0
Target: 0
Max: 100
23
Are regular internal audits conducted on the LIMS?
24
List the corrective actions taken in response to identified quality issues.
25
When was the last compliance training held for LIMS users?

FAQs

The checklist covers areas such as user access controls, data entry and modification, audit trails, electronic signatures, instrument integration, sample management, and reporting functionalities.

It includes sections on data input validation, data storage security, backup procedures, archive management, and mechanisms to prevent unauthorized data alterations.

Yes, the checklist is designed to be applicable for both commercial LIMS products and custom-developed laboratory information management systems.

It includes sections on instrument interfacing, data transfer validation, calibration management, and ensuring data integrity during automated data acquisition from instruments.

The checklist covers initial system validation, change control procedures, periodic review processes, and ongoing performance qualification of the LIMS.

Benefits of Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist

Ensures LIMS compliance with FDA 21 CFR Part 11 regulations

Improves data integrity and traceability in pharmaceutical laboratories

Enhances efficiency and accuracy of laboratory operations

Facilitates easier regulatory inspections and audits of laboratory systems

Supports integration of LIMS with other quality management systems