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GLP Archive Management and Record Retention Audit Checklist

A comprehensive checklist for auditing archive management practices and record retention processes in GLP-regulated pharmaceutical research, ensuring long-term data integrity and regulatory compliance.

GLP Archive Management and Record Retention Audit Checklist

by: audit-now
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About This Checklist

Proper management of archives and retention of records is a critical aspect of Good Laboratory Practice (GLP) compliance in pharmaceutical research. This GLP Archive Management and Record Retention Audit Checklist is designed to help archivists, records managers, and quality assurance personnel evaluate and improve processes related to the storage, retrieval, and maintenance of GLP study data and documentation. By implementing this checklist, pharmaceutical organizations can ensure long-term data integrity, meet regulatory requirements for record keeping, and facilitate efficient retrieval of historical study information when needed.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research Facilities

Occupations

Archive Manager
Records Management Specialist
Quality Assurance Officer
GLP Compliance Manager
Information Governance Specialist
1
What is the location of the archive facility?
2
When was the last audit conducted at this archive facility?
3
What is the current compliance status of the archive facility?
4
Are data integrity checks performed regularly on archived records?
5
What are the specific storage conditions for the archived records?
6
What is the retention period for the archived records in years?
Min: 1
Target: 5
Max: 30
7
What is the current access control status for the archived records?
8
When is the next scheduled review of the archived records?
9
What are the documented procedures for managing archived records?
10
Is regular training provided to staff on GLP compliance and archive management?
11
What is the status of the record retention policy?
12
When was the last update made to the archived records?
13
What is the maintenance schedule for the archive facility?
14
How many studies are currently archived in the facility?
Min: 1
Target: 100
Max: 10000
15
What is the frequency of reviews conducted for the archived records?
16
When was the last maintenance conducted on the archive facility?
17
What are the procedures for backing up archived data?
18
Is encryption used for stored electronic records?
19
What physical security measures are in place for the archive facility?
20
When was the last security audit of the archive facility conducted?

FAQs

The checklist covers areas such as archive facility conditions, access controls, indexing and cataloging systems, retention period compliance, electronic data archiving, backup procedures, retrieval processes, and destruction protocols for expired records.

Comprehensive audits should be conducted annually, with more frequent checks on critical aspects such as environmental conditions and access logs. Additionally, spot checks on record retrieval and integrity should be performed periodically.

The audit should be conducted by a team including the archive manager, quality assurance personnel, IT representatives (for electronic records), and GLP compliance officers to ensure a thorough assessment of all archiving aspects.

By ensuring proper archiving and retention of study records, this checklist helps maintain the long-term integrity and traceability of research data, supporting potential future study reconstructions and demonstrating ongoing GLP compliance.

Yes, the checklist is designed to address both traditional paper-based archives and modern electronic archiving systems, ensuring comprehensive coverage of all types of GLP study records and data storage methods.

Benefits of GLP Archive Management and Record Retention Audit Checklist

Ensures compliance with GLP regulations for record retention and archiving

Enhances long-term data integrity and traceability of research studies

Improves efficiency in retrieving historical study data and documentation

Reduces risks associated with data loss or deterioration over time

Supports preparedness for regulatory inspections and study reconstructions