Establishment and Control of Archives that Operate in Compliance with the Principles of GLP [electronic resource] /
Organisation for Economic Co-operation and Development.
Organisation for Economic Co-operation and DevelopmentContributor
Paris : OECD Publishing,
2007.
This document is intended for use by test facilities that are required to operate in compliance with the Principles of GLP, for organisations that supply support, e.g. contract archives, contract quality assurance units or IT services and for sponsors, GLP compliance monitoring authorities and receiving authorities. Organisations should ensure that they evaluate applicable regulatory requirements against their business needs. Certain aspects of archive construction and operation may have implications for compliance with building regulations or legislation regarding public health and safety. Guidance on these aspects is outside the scope of this document. Test facilities and other organisations, engaged in archiving GLP records and material, might benefit from the use of recognised archiving management standards including those concerning metadata.
1. Introduction 9 2. Scope 9 3. Definition of Tterms 10 4. Roles and Responsibilities 11 -4.1 Sponsor 11 -4.2 Test Facility Management 11 -4.3 Archive Contracting Facility 11 -4.4 Test Site Management 11 -4.5 Study Director 12 -4.6 Principal Investigator 12 -4.7 Archivist 12 -4.8 Information Technology (IT) Personnel 12 -4.9 Quality Assurance (QA) Personnel 12 5. Archive Facilities 13 -5.1 Archive Conditions13 -5.2 Disaster Recovery 13 6. Security 14 -6.1 Physical and Operational Security 14 -6.2 Access to the Archive 14 7. Archiving Procedures 15 -7.1 Standard Operating Procedures 15 -7.2 Records and Materials to be retained 15 -7.3 Indexing 17 -7.4 Placement of Records and Materials into the Archives 17 -7.5 Transfers 17 -7.6 Retention Period 18 -7.7 Retrieval 18 -7.8 Disposal of Records and Materials 19 8. Archiving Electronic Records 20 -8.1 Decision to Retain Records Electronically 20 -8.2 Storage Media 20 -8.3 Defined Archive Area on a Computerised System 20 -8.4 Dedicated Electronic Archive System 20 -8.5 Maintenance and Preservation of Electronic Records 21 9. Quality Assurance 22 10. Contract Aarchive Services 22 -10.1 Contracts and/or Service Level Agreements 22 -10.2 Access Arrangements 22 -10.3 Conditions of Storage 22 -10.4 Inspections 22 11. Closure of an Archive 23 -11.1 Principle 23 -11.2 Measures to be Taken 23 -11.3 Inspections by Monitoring Authorities 23 12. References 24
This document is intended for use by test facilities that are required to operate in compliance with the Principles of GLP, for organisations that supply support, e.g. contract archives, contract quality assurance units or IT services and for sponsors, GLP compliance monitoring authorities and receiving authorities. Organisations should ensure that they evaluate applicable regulatory requirements against their business needs. Certain aspects of archive construction and operation may have implications for compliance with building regulations or legislation regarding public health and safety. Guidance on these aspects is outside the scope of this document. Test facilities and other organisations, engaged in archiving GLP records and material, might benefit from the use of recognised archiving management standards including those concerning metadata.
Bibliographic Level Mode of Issuance: Monograph
Environment
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring