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.

by: audit-now

4.8

Get Template

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.

Learn more

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

Data Integrity and Audit Trail Evaluation

Is the audit trail for all cleanroom activities complete?

Are data entry procedures documented and followed?

What is the error rate in data entry for the last quarter?

Min: 0

Target: 2%

Max: 100

Are data access controls adequate and enforced?

Quality Assurance and Compliance Checks

Is the frequency of quality control reviews adequate?

Are corrective actions from previous audits implemented effectively?

What is the completion rate of training for staff on SOPs?

Min: 0

Target: 95%

Max: 100

Is the facility compliant with relevant regulatory requirements?

Cleanroom Operational Standards Assessment

Are personnel hygiene practices compliant with cleanroom standards?

Are equipment maintenance logs up to date and properly documented?

What is the accuracy level of temperature control in the cleanroom?

Min: 0

Target: ±1°C

Max: 5

Are cleaning protocols adhered to as per defined SOPs?

Validation and Verification Processes Review

Is the process validation status up to date and compliant with regulations?

Is all change control documentation complete and properly reviewed?

What is the deviation rate reported in the last audit cycle?

Min: 0

Target: 3%

Max: 100

Is the verification of equipment calibration performed regularly?

Identifiers

Auditor Name

Site/Location

Date

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

FAQs

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

Data Integrity and Audit Trail Evaluation

Quality Assurance and Compliance Checks

Cleanroom Operational Standards Assessment

Validation and Verification Processes Review

Identifiers

FAQs

What key areas does the Documentation and Record-Keeping Audit Checklist cover?

How does proper documentation contribute to cleanroom management?

Who should be involved in conducting the documentation and record-keeping audit?

How frequently should cleanroom documentation audits be performed?

What actions should be taken if the audit reveals gaps in documentation practices?

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

Data Integrity and Audit Trail Evaluation

Quality Assurance and Compliance Checks

Cleanroom Operational Standards Assessment

Validation and Verification Processes Review

Identifiers

FAQs

What key areas does the Documentation and Record-Keeping Audit Checklist cover?

How does proper documentation contribute to cleanroom management?

Who should be involved in conducting the documentation and record-keeping audit?

How frequently should cleanroom documentation audits be performed?

What actions should be taken if the audit reveals gaps in documentation practices?

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