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ISO 14644 Cleanroom Documentation and Record-Keeping Audit Checklist

A comprehensive checklist for auditing documentation and record-keeping practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on the creation, maintenance, and management of essential records to support regulatory compliance and operational excellence.

ISO 14644 Cleanroom Documentation and Record-Keeping Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Documentation and Record-Keeping Audit Checklist is a critical tool for ensuring comprehensive and accurate documentation in pharmaceutical cleanroom operations. This checklist aligns with ISO 14644 standards, focusing on the creation, maintenance, and management of essential records and documentation related to cleanroom activities. By systematically evaluating documentation practices, pharmaceutical companies can enhance traceability, support regulatory compliance, and facilitate continuous improvement in cleanroom operations. Regular implementation of this checklist strengthens data integrity, aids in root cause analysis of deviations, and provides a robust foundation for quality assurance in pharmaceutical manufacturing.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Quality Assurance Specialist
Document Control Officer
Cleanroom Manager
Regulatory Compliance Officer
Data Integrity Specialist
1
Is cleanroom documentation maintained in accordance with ISO 14644 standards?

Select compliance status.

To ensure that documentation practices meet regulatory requirements.
2
Are environmental monitoring logs complete and accessible?

Provide details about the accessibility and completeness of logs.

To verify that logs are maintained for quality assurance.
3
What is the record retention period for cleanroom documentation?

Specify the retention period in years.

To ensure compliance with regulatory requirements for record-keeping.
Min: 1
Target: 5 years
Max: 10
4
Are standard operating procedures (SOPs) consistently followed?

Select adherence level.

To assess compliance with internal quality assurance practices.
5
Is the audit trail for all cleanroom activities complete?

Select the status of the audit trail.

To ensure all activities are documented for accountability and traceability.
6
Are data entry procedures documented and followed?

Provide details on the documentation and adherence to data entry procedures.

To verify that data integrity practices are adhered to.
7
What is the error rate in data entry for the last quarter?

Specify the error rate as a percentage.

To assess the accuracy of data entry processes.
Min: 0
Target: 2%
Max: 100
8
Are data access controls adequate and enforced?

Select the level of adequacy of data access controls.

To ensure that sensitive data is protected from unauthorized access.
9
Is the frequency of quality control reviews adequate?

Select the frequency adequacy of quality control reviews.

To ensure that quality control measures are regularly assessed for effectiveness.
10
Are corrective actions from previous audits implemented effectively?

Provide details on the implementation of corrective actions.

To verify that identified issues are addressed to prevent recurrence.
11
What is the completion rate of training for staff on SOPs?

Specify the training completion rate as a percentage.

To ensure that staff are adequately trained on standard operating procedures.
Min: 0
Target: 95%
Max: 100
12
Is the facility compliant with relevant regulatory requirements?

Select the compliance status.

To assess the overall compliance status of the facility in relation to regulations.
13
Are personnel hygiene practices compliant with cleanroom standards?

Select the compliance status of personnel hygiene practices.

To ensure that all personnel adhere to hygiene protocols to maintain cleanroom integrity.
14
Are equipment maintenance logs up to date and properly documented?

Provide details about the maintenance logs.

To verify that all equipment is maintained to ensure operational efficiency.
15
What is the accuracy level of temperature control in the cleanroom?

Specify the temperature control accuracy range.

To ensure that temperature control measures are effective and within acceptable limits.
Min: 0
Target: ±1°C
Max: 5
16
Are cleaning protocols adhered to as per defined SOPs?

Select the adherence level to cleaning protocols.

To assess the effectiveness of cleaning practices in maintaining cleanroom standards.
17
Is the process validation status up to date and compliant with regulations?

Select the validation status of processes.

To ensure that all processes are validated and compliant with industry standards.
18
Is all change control documentation complete and properly reviewed?

Provide details regarding the change control documentation.

To verify the integrity of the change control process and its documentation.
19
What is the deviation rate reported in the last audit cycle?

Specify the deviation rate as a percentage.

To assess the frequency and impact of deviations from established processes.
Min: 0
Target: 3%
Max: 100
20
Is the verification of equipment calibration performed regularly?

Select the frequency of equipment calibration verification.

To ensure that all equipment remains accurate and reliable for operations.

FAQs

The checklist covers standard operating procedures (SOPs), environmental monitoring logs, equipment calibration records, personnel training documentation, cleaning and maintenance records, and change control documentation related to cleanroom operations.

Comprehensive documentation provides a clear audit trail, supports decision-making processes, aids in identifying trends or issues, and demonstrates compliance with regulatory requirements and internal standards.

The audit should involve quality assurance personnel, document control specialists, cleanroom managers, and regulatory compliance officers to ensure a thorough evaluation of all documentation aspects.

Comprehensive audits should be conducted semi-annually, with ongoing spot checks of critical documentation. Electronic record systems should be reviewed for integrity and security on a quarterly basis.

Identified gaps should trigger immediate corrective actions, including updating of SOPs, retraining of personnel on documentation practices, and implementation of improved record-keeping systems. A follow-up audit should be scheduled to verify the effectiveness of these actions.

Benefits of ISO 14644 Cleanroom Documentation and Record-Keeping Audit Checklist

Ensures compliance with ISO 14644 documentation requirements for cleanroom operations

Enhances traceability and accountability in cleanroom activities

Facilitates efficient regulatory inspections and audits

Supports data integrity and reliability in cleanroom record-keeping

Aids in trend analysis and continuous improvement of cleanroom processes