good laboratory practice and compliance monitiring
Unclassified ENV/JM/MONO(2007)10 Organisation de Coopération et de Développement Economiques Organisation for Economic Co-operation and Development 11-Jun-2007 ___________________________________________________________________________________________English - Or. English ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY
OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 15 Advisory Document of the Working Group on Good Laboratory Practice Establishment and Control of Archives that Operate in Compliance with the Principles of GLP JT03228850
ENV/JM/MONO(2007)10 Unclassified English - Or. English Cancels & replaces the same document of 04 June 2007
ENV/JM/MONO(2007)10
ENV/JM/MONO(2007)10
OECD Environment, Health and Safety Publications
Series on Principles of Good Laboratory Practice
and Compliance Monitoring
No. 15
Advisory Document of the Working Group on Good
Laboratory Practice
Establishment and Control of Archives that Operate
in Compliance with the Principles of GLP
Environment Directorate
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris 2007
ENV/JM/MONO(2007)10
ALSO PUBLISHED IN THE SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE
AND COMPLIANCE MONITORING
?No. 1, OECD Principles of Good Laboratory Practice (as revised in 1997)
?No. 2, Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995)
?No. 3, Revised Guidance for the Conduct of Laboratory Inspections and Study Audits (1995) ?No. 4, Quality Assurance and GLP (as revised in 1999)
?No. 5, Compliance of Laboratory Suppliers with GLP Principles (as revised in 1999)
?No. 6, The Application of the GLP Principles to Field Studies (as revised in 1999)
?No. 7, The Application of the GLP Principles to Short-term Studies (as revised in 1999)
?No. 8, The Role and Responsibilities of the Study Director in GLP Studies (as revised in 1999) ?No. 9, Guidance for the Preparation of GLP Inspection Reports (1995)
?No. 10, The Application of the Principles of GLP to Computerised Systems (1995)
?No. 11, The Role and Responsibilities of the Sponsor in the Application of the principles of GLP (1998)
?No. 12, Requesting and Carrying Out Inspections and Study Audits in Another Country (2000) ?No. 13, The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002)
?No. 14, The Application of the Principles of GLP to in vitro studies (2004)
? OECD 2007 Applications for permission to reproduce or translate all or part of this material should be made to:Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France.
ENV/JM/MONO(2007)10 About the OECD
The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental
organisation in which representatives of 30 industrialised countries in North America, Europe and the Asia
and Pacific region, as well as the European Commission, meet to co-ordinate and harmonise policies,
discuss issues of mutual concern, and work together to respond to international problems. Most of the
OECD’s work is carried out by more than 200 specialised committees and working groups composed of
member country delegates. Observers from several countries with special status at the OECD, and from
interested international organisations, attend many of the OECD’s workshops and other meetings.
Committees and working groups are served by the OECD Secretariat, located in Paris, France, which is
organised into directorates and divisions.
The Environment, Health and Safety Division publishes free-of-charge documents in nine different series:
Testing and Assessment; Good Laboratory Practice and Compliance Monitoring; Pesticides and
Biocides; Risk Management; Harmonisation of Regulatory Oversight in Biotechnology; Safety of
Novel Foods and Feeds; Chemical Accidents; Pollutant Release and Transfer Registers; and
Emission Scenario Documents. More information about the Environment, Health and Safety Programme
and EHS publications is available on the OECD’s World Wide Web site (https://www.sodocs.net/doc/3510185620.html,/ehs/).
This publication was produced within the framework of the Inter-Organisation Programme for the
Sound Management of Chemicals (IOMC).
The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was
established in 1995 following recommendations made by the 1992 UN Conference on
Environment and Development to strengthen co-operation and increase international co-
ordination in the field of chemical safety. The participating organisations are FAO, ILO,
OECD, UNEP, UNIDO, UNITAR and WHO. The World Bank and UNDP are observers. The
purpose of the IOMC is to promote co-ordination of the policies and activities pursued by the
Participating Organisations, jointly or separately, to achieve the sound management of
chemicals in relation to human health and the environment.
ENV/JM/MONO(2007)10
This publication is available electronically, at no charge.
For this and many other Environment,
Health and Safety publications, consult the OECD’s
World Wide Web site (https://www.sodocs.net/doc/3510185620.html,/ehs/)
or contact:
OECD Environment Directorate,
Environment, Health and Safety Division
2 rue André-Pascal
75775 Paris Cedex 16
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Fax: (33-1) 44 30 61 80
E-mail: ehscont@https://www.sodocs.net/doc/3510185620.html,
ENV/JM/MONO(2007)10
FOREWORD
The OECD Working Group on Good Laboratory Practice, at its 17th meeting in 2003, established a
drafting group under the leadership of the Netherlands (Mr. Theo Helder), with participation by Germany,
Italy, Sweden, Switzerland the United Kingdom and the United States. After reviewing existing material
on archiving in a GLP environment, the group develop a first draft document, which was reviewed by the
Working Group at its 20th meeting in 2006.
The Working Group agreed that it would circulate the draft for comment to stakeholders in industry
and receiving authorities and that Members would prepared consolidated national comments. Comments
were received from Australia, Belgium, Denmark, Finland, Germany, Ireland, Israel, Italy, Japan, Korea,
Netherlands, Slovenia, Spain, Sweden, Switzerland, and United States. The Working Group then
reviewed, amended and endorsed a revised version of the document at its 21st Meeting in 2007.
The Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and
Biotechnology endorsed the document on 25 May 2007and agreed that it be declassified and published in
the OECD series on GLP and Compliance Monitoring as an Advisory Document of the Working Group on
GLP.
ENV/JM/MONO(2007)10
TABLE OF CONTENTS
1. INTRODUCTION (9)
2. SCOPE (9)
3. DEFINITION OF TERMS (10)
4. ROLES & 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 Conditions (13)
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 ARCHIVE 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)
ENV/JM/MONO(2007)10 Advisory Document of the Working Group on GLP
ESTABLISHMENT AND CONTROL OF ARCHIVES THAT OPERATE IN COMPLIANCE
WITH THE PRINCIPLES OF GLP
1. INTRODUCTION
The archiving of records and materials generated during the course of a non-clinical health or
environmental safety study is an important aspect of compliance with the Principles of Good Laboratory
Practice (GLP). The maintenance of the raw data associated with a specific study and the specimens
generated from that study are the only means that can be used to reconstruct the study, enabling the
information produced in the final report to be verified and the compliance with GLP of a specific study to
be confirmed.
The purpose of the guidance contained in this document is to assist in conforming to the requirements
of the OECD Principles of Good Laboratory Practice as they relate to archiving.
This guidance does not supersede any requirement set out in national regulations and/or legislation,
e.g. pertaining to the timeliness of archiving or retention periods.
2. SCOPE
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.
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3. DEFINITION OF TERMS
Archive: A designated area or facility (e.g. cabinet, room, building or computerised system) for the secure storage and retention of records and materials.
Archive Staff: Individuals who work under the supervision of the archivist and who are responsible for the routine archive operations.
Archivist: An individual designated by test facility or test site management to be responsible for the management of the archive, i.e. for the operations and procedures for archiving.
Electronic archives: Facilities and systems provided to maintain electronic records as required by the Principles of GLP.
Electronic record: All original laboratory records and documentation, including data directly entered into a computer through an instrument interface, which are the results of original observations and activities in a study and which are necessary for the reconstruction and evaluation of the report of that study.
Metadata: Data that describe the attributes of other data. Most commonly these are data that describe the structure, data elements, inter-relationships and other characteristics of electronic records. Migration: The transfer of electronic records from one format, media or computerised system to another. System Owner: The manager, or designee, of the department that is most impacted by, or is the primary user of, the system.
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4. ROLES & RESPONSIBILITIES
4.1 Sponsor
The sponsor is assumed to play an active role in confirming that all non-clinical health and
environmental safety studies are conducted in compliance with GLP.
The sponsor therefore should ensure that materials and records in support of regulatory studies are
retained and maintained under conditions that ensure their integrity and continued access. Also if records
and materials are transferred into the sponsor’s possession, storage should be in archives that meet the
requirements of the Principles of GLP. The sponsor should also ensure that such material and records are
retained for as long as required by relevant authorities. The archive and retained materials and records
should be available for inspection during normal office hours. If electronic records are kept, it should be
possible to make them available in human readable form.
4.2 Test Facility Management
Test facility management is responsible for the provision of archive facilities. Test facility
management is also responsible for the appointment of an individual and, if necessary, additional archive
staff for the operation of the archives. A back-up archivist should also be appointed to perform the duties
of the archivist in the event that the archivist is unable or unavailable to perform the archivist’s duties.
These appointments should be documented. When appointing the archivist and the back-up archivist, test
facility management should avoid possible conflicts of interest through incompatibilities of functions.
Test facility management should ensure that the records and materials generated in the test facility
that are necessary to reconstruct studies, and the documentation required to demonstrate the GLP
compliance of the test facility, are archived.
Test facility management should ensure that appropriate archiving procedures are established.
Test facility management should ensure that only selected authorised personnel shall have access to
the archive(s). Access should be controlled and the accessing procedure should be documented. Security
and technical personnel should be granted access only when necessary (e.g. in case of emergencies) also in
a controlled and documented manner.
Test facility management might be expected to inform sponsors on GLP requirements and the
responsibilities of the sponsor regarding archiving where necessary.
4.3 Archive Contracting Facility
If a sponsor or test facility management uses a contract archive for the storage of records and/or
materials for a GLP study, the contracting parties should ensure compliance with the relevant sections of
the Principles of GLP.
4.4 Test Site Management
Test site management has the same responsibilities as test facility management with regards to archive
facilities and procedures at their own site.
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4.5 Study Director
The Study Director is responsible for ensuring that during or immediately after completion (including termination) of a study, all study related records and materials are transferred to the archive(s). The Study Director is responsible for the completeness of the study records and materials and for assuring that all materials are archived before or at the close of the study.
4.6 Principal Investigator
A Principal Investigator should ensure that records and materials for which he/she is responsible are sent to the Study Director, or transferred to an agreed archive location latest upon completion of the study or phase of the study. The Principle Investigator should inform the Study Director about the date of transfer or archiving.
4.7 Archivist
The archivist is responsible for the management, operations and procedures for archiving in accordance with established Standard Operating Procedures, and the Principles of GLP.
The archivist should therefore, inter alia,
?ensure that access to the archive is controlled;
?ensure that the orderly storage and retrieval of records and materials is facilitated by a
system of indexing; and
?ensure that movement of records and materials in and out of the archives is properly
controlled and documented
Where there is a need for several staff to perform archiving duties, staff should work under the direction and supervision of the designated archivist. It is recognized that in certain circumstances it may be necessary for the archivist to delegate specific archiving tasks, for example management of electronic record. Respective tasks, duties and responsibilities have to be specified and detailed in SOPs.
4.8 Information Technology (IT) Personnel
IT personnel involved in archiving operations (such as ensuring integrity of electronic records) should be adequately trained and their activities should conform to GLP requirements. Since activities pertaining to archiving are the primary responsibility of the archivist, these IT personnel ideally should work under the direction and supervision of the archivist. Because it is recognised that such organisational structures are not feasible in modern companies, the co-operation between the archivist and IT personnel should be ensured in other ways, for instance in SOPs or written service level agreements.
4.9 Quality Assurance (QA) Personnel
QA personnel are responsible for inspecting all aspects of archiving for compliance with the Principles of GLP. This includes the inspection of archiving operations and procedures, including procedures for electronic records, facilities, stored records and materials.
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5. ARCHIVE FACILITIES
The archive facility should be suitably designed and constructed to accommodate the archived records
and materials. This may be one or more buildings, rooms, safes or lockable cabinets or other locations that
provide suitable security. The archive facility should be physically secure to prevent unauthorised access to
the retained records and materials. The use of locks or electronic entry systems is required. The
components that provide storage of unique electronic records should also be physically secure. The
computerised archive facility should have processes to prevent unauthorised access and virus protection.
The building(s) or room(s) that house the archive should be constructed to withstand the elements of
local weather, etc. Consideration may need to be given to specific local conditions such as a risk of
flooding. The archive design should protect the contents from untimely deterioration for example by
leakage of running water pipes in the archive areas. The risk of fire and explosion should be minimised. In
most circumstances it will be necessary that an automated fire and/or smoke detection system be installed.
Management may also consider an automated fire suppression system that minimises the risk of damage. If
there is a risk of flooding, a water detector and/or water drain should be considered.
The archive facility should be designed to prevent the entry of rodent and insect pests. Where
appropriate, pest control procedures should be in place.
Where necessary, back-up electrical power should be provided for all temperature-critical equipment
(e.g., refrigerators and freezers).
5.1 Archive Conditions
Storage conditions should be designed to preserve and not adversely affect the quality and integrity of
retained records and materials. Special storage conditions may be required to maintain the integrity of
some retained record(s) and material(s) for the specified retention period(s). For example, it might be
appropriate to store wet tissues, blocks and reserve samples of test items separate from paper and histology
slides.
Special storage conditions may be required for particular materials. Examples are materials required
to be stored frozen, refrigerated, desiccated, etc., or free from dust or magnetic interference in the case of
electronic media. The need for special storage conditions should be defined in relevant test facility
Standard Operating Procedures.
If special storage conditions have been defined, environmental monitoring procedures should be
implemented within archive storage areas to confirm that specified conditions of storage are being
achieved.
Where continuous (automated) monitoring systems are used (which may also act as alarms that are
activated in the event that defined conditions are outside specified limits), these systems should be
regularly maintained, tested, and verified, and records thereof retained, as required by the Principles of
GLP.
5.2 Disaster Recovery
Test facilities and contract archives should have procedures in place to minimise damage to archived
records and materials caused by adverse events. Some of the more common adverse events to be
considered include fire, electrical failure, extreme weather-related damage, flooding, theft, and sabotage.
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The procedures may cover protective measures that may be implemented, as well as the recovery and/or restoration of lost or damaged records and materials and re-establishment of security. The plan should include useful and emergency contacts, the location of necessary equipment, and the records that should be made (e.g., documentation of the event and the steps taken to resolve and/or restore).
6. SECURITY
6.1 Physical and Operational Security
The archive facility should be both physically and operationally secure to prevent unauthorised access and changes to or loss of retained records and materials. Test facility management should ensure security by implementing appropriate measures that should be described in the test facility’s SOPs.
The security controls necessary to restrict access to electronic records will usually be different from those applied to other record types. Since many electronic storage media can be re-used (e.g. overwritten), measures should be implemented to ensure that records cannot be altered or deleted.
6.2 Access to the Archive
With normal archive operations, access to the archive should be controlled by and restricted to the archivist and archive staff. For emergency access (especially during off-hours or for safety reasons), emergency personnel may enter and/or operate the archive unaccompanied. Otherwise visitors should be accompanied by the archivist or a member of the archive staff. The procedures for access to archive storage areas should be documented. The record of such visits should be retained. For electronic archives the above mentioned restrictions might not be applicable, but as a minimum deletion or alteration of electronic records in electronic archives should be avoided. Management might authorise read-only access on electronic records to a broader community.
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7. ARCHIVING PROCEDURES
7.1 Standard Operating Procedures
The following issues should be addressed in the Archive Standard Operating Procedures, where
applicable:
?Access to the archives
?Definition and description of the archive
?Indexing procedures, including electronic records
?Conditions under which records and materials should be stored
?Procedures for the receipt of records and materials to be archived
?Procedures for accessing, removal and return of records and materials
?Responsibilities of the archivist and archiving staff
?Security of the archive facility and the records and materials retained
?Climate control
?Retention period
?Disposal of archived records and materials
?Contract archiving services, if applicable
?Transfer to sponsors or third parties, if applicable
?Disaster recovery
?Training requirements for the archivist and archiving staff
?Frequency of archiving non-study specific records
?Periodic refreshing of electronic records
7.2 Records and Materials to be retained
Records to be retained include paper records, photographs, microfilms or microfiches, computer
media, dictated observations, recorded data from automated instruments, or any other storage medium
containing the data generated in the conduct of a non-clinical health or environmental safety study.
Materials to be retained include wet tissues, paraffin blocks, specimens, slides, smears, test materials /
retention samples, etc. Records and materials may be study-specific, or relate to more than one study.
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7.2.1 Study-specific records and materials
These are the records and materials generated during the conduct of a single study in accordance with the study plan. The Study Director is responsible for ensuring these records and materials are transferred to the archives latest after study completion. These records may be inspected for verification of the results reported from a specific study and for the general assessment of the compliance of the study with Principles of GLP. The following are examples of study-specific records and materials that should be retained in the archives.
?Study plan, raw data, and the final report of each study
?Other study related documents and communication such as e.g. delivery receipts, phone notes, faxes etc.
?Samples of test and reference items
?Specimens
?Certificates of Analysis
7.2.2 Facility records and materials
These are records and materials that are generated by a test facility/site, and may be specific to one or more studies performed at the facility/site. Such records and materials may be inspected for the reconstruction of a study and for the general assessment of the continuing compliance of a test facility with Principles of GLP. Management should address in an SOP how and by whom the archiving of these records and materials should be carried out.
The following are examples of facility records and materials that should be retained:
?Records of all inspections performed by the Quality Assurance
?Master Schedules
?Organisational charts
?Floor/site plans
?Records of qualifications, training, experience and job descriptions of personnel
?Records and reports of the maintenance and calibration of apparatus
?Validation documentation for computerised systems
?Historical files of all Standard Operating Procedures
?Environmental monitoring records
?Samples of test and reference items, if used for more than one study
?Certificates of Analysis, if used for more than one study
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7.3 Indexing
The Principles of GLP require that records and materials retained in the archives be indexed so as to
facilitate orderly storage and rapid retrieval. The system of indexing employed should facilitate the
retrieval of all information required to reconstruct a study from both the study and the facility records.
7.4 Placement of Records and Materials into the Archives
On completion (including termination) of a study the Study Director is responsible for ensuring that
all study documentation, data and related records and materials are archived in a timely manner. The Study
Director retains responsibility for the integrity of study documentation, data and related records and
materials until they are accepted into the archive. Test facility management is responsible for maintaining
the integrity of the records and materials once they are transferred to the archives. Test facility
management should ensure that a time period for the transfer of material from the Study Director to the
archivist is defined that is in compliance with national regulatory requirements, where existent.
Prior to transferring records and materials to the archive, the Study Director is responsible for
establishing an inventory to be archived, confirming completeness of records and materials, and ensuring
that these records and materials are transferred in their entirety to the archive. The archivist or archive
personnel should check the completeness of records and materials upon their arrival by comparison with
the inventory list and acknowledge receipt.
Test Facility Management should ensure that non study specific (facility) records such as maintenance
records, staff training records, organisational charts, etc. are archived on a regular basis defined by test
facility SOP. Procedures for archiving these records and materials should be similar to those employed for
study records and materials.
In multi-site studies, procedures for archiving records and materials generated at individual test sites
should be agreed upon and documented prior to/ or at the initiation of the study.
The Principal Investigator should notify the Study Director of the transfer of study materials to the
archive.
7.5 Transfers
On occasion it may be necessary to transfer archived records and materials from one archive to
another at a different physical location. The archivist transferring the records and materials, including
electronic records, should ensure that there is a documented agreement and transfer plan between test
facility management, management at the receiving facility and the sponsor before any transfer occurs. The
documentation should include details of the records and materials to be transferred, the contact
details/address of the receiving facility, and the means of transfer between locations.
Records and materials to be transferred should be clearly described in appropriate chain of custody
documentation prepared by the archivist. The transportation of the material, and associated paperwork,
between the two locations should be undertaken in such a way as to minimise the risk of loss or damage of
the records and materials.
The recipient of the transferred records and materials should check that they correspond with the
associated chain of custody documentation, and once accepted, the recipient becomes responsible for
ensuring that anything is maintained and preserved appropriately. All parties involved in the transfer
ENV/JM/MONO(2007)10
should retain copies of the chain-of-custody documentation. Transfer of archived materials between computerised archive systems should be documented and conducted according to a migration plan.
7.6 Retention Period
Retention periods should be, and in some countries are, defined by regulatory (receiving) authorities. The retention period defines the minimal period of time that data must be retained and must be available for review if the safety studies that support the registration of new products or marketed products need to be verified. It is strongly recommended that records and other sustaining material associated with such safety studies be retained for as long as regulatory authorities might request GLP audits of the respective studies.
When performing routine test facility inspections that include the carrying out of study audits, monitoring authorities and/or their inspectors will normally select studies completed or performed since the previous inspection or, in some countries, the two previous inspections. If the retention periods have not been defined by an applicable regulatory authority, it is highly recommended that records and materials should be retained for at least three inspection cycles so that inspectors can evaluate the compliance of the test facility with the Principles of GLP. For those studies that will not be submitted to regulatory authorities it may be acceptable (if justified) to dispose of the study specific records and materials after this period.
The Principles of GLP state: “a sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies”. Samples of test and reference items may however be discarded when the quality of the material no longer permits evaluation. Obviously the storage conditions should be optimal for these samples. When samples of test and reference items or specimens are disposed of before the end of the required retention period, the reason for disposal should be justified and documented.
Perishable specimens, such as blood smears, freeze-dried preparations and wet tissues, may also be discarded when they can no longer be read or evaluated. For non-perishable specimens the general guidance will apply.
Electronic media may be discarded when the media itself no longer permits evaluation (due to hardware or software issues) provided the disposal is authorized, documented, and electronic records are migrated and any record losses documented.
7.7 Retrieval
Appropriate procedures should be established for retrieval of archived records and materials. These procedures should define the circumstances under which they may be removed from the archive (e.g. for inspection/ regulatory purposes, by sponsor, etc.). The procedures should also describe in detail who is permitted to withdraw records and materials, who can authorise removal of records and materials and the timeframe within which records and materials should be returned to the archives.
Viewing electronic records without the possibility of alteration or deletion of the archived electronic record or replicating within another computerized system does not constitute “retrieval” of a record.
The Principles of GLP require that movement of records and materials in and out of the archives should be properly recorded. There should be mechanisms in place to enable the archivist to track the movement of records and materials from and back to the archive and to identify any records and materials
ENV/JM/MONO(2007)10 not returned within the specified timeframe. On return to the archive, the records and materials should be
verified by the archivist or a designed member of the archive staff to be complete and unaltered.
Management should be informed of any discrepancies.
7.8 Disposal of Records and Materials
Test facility management’s and, if applicable, the sponsor’s authorisation should be obtained before
the disposal of any archived records and materials. The reasons for disposal should be recorded. It may be
appropriate to inform QA. The disposal of archived records and materials should be documented.
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8. ARCHIVING ELECTRONIC RECORDS
Requirements for the archiving of electronic records are the same as those for other record types, but there are additional features, which are addressed below. It is therefore important that management ensure that appropriate Standard Operating Procedures are established for the archiving of electronic media in a secure GLP environment.
8.1 Decision to Retain Records Electronically
The decision to retain records in electronic form has important implications. The long-term retention of electronic records may influence the choice of storage medium since deterioration of storage media can lead to permanent loss of records. Computer technology is developing rapidly and devices capable of reading storage media in common use today may not be available in the future. Electronic records should be stored in a format that is readable for the duration of the applicable record retention period.
8.2 Storage Media
Records may be migrated from a computerised system onto a storage medium, e.g. magnetic tape, diskette, CD or optical disk that can be placed in a physical archive. Archive procedures should include the consideration of additional controls for the migration of electronic records from old to new media of these records. Consideration should be given to future access to the data or records stored on these media. There may be a need for special storage conditions, e.g. protection from magnetic fields.
8.3 Defined Archive Area on a Computerised System
Electronic records may be moved from the production part of a computerised system to a discrete, secure archive area on the same computer system (physically separated, e.g. file record systems), or explicitly marked as archived (logically separated, e.g., database record systems). Records should be “locked” such that they can no longer be altered or deleted without detection. Records archived in this way must be under the control of a designated archivist and be subject to equivalent controls to those applied to other record types.
8.4 Dedicated Electronic Archive System
Records may be migrated from the computer system that captured or manipulated them into a separate dedicated electronic archive system. All data associated with the reconstruction of the study needs to be migrated. This includes, but is not limited to raw data, metadata, audit trails, e-signatures and associated hardware and software that allow availability of all records in the future.
Where ideally the archivist should be the system-owner for the electronic archive system, it is recognised that the electronic archive system is likely to be managed by information technology (IT) personnel. The archivist, being ultimately responsible for managing the archive, has an important role in helping to ensure that regulatory requirements are met. Test facility management should, therefore, take care that the co-operation and co-ordination between the archivist and information technology personnel is ensured.
These IT staff should follow procedures agreed with the archivist and/or test facility management.
北大中文系比较文学概论笔记
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了孩子的胃口，孩子会处于一种消极状态。因此，在实际教学活动中，我们选取合适的教学方法，提高幼儿学英语的兴趣。 1、故事教学法。 故事对学龄前幼儿具有极大的吸引力，它情节生动活泼，内容极富发性和趣味性，例如在故事<聪明兔宝宝>中,先为孩子们讲一个兔妈妈要去买菜，要兔宝宝在家等候，却来了一只大灰狼要兔宝宝开门，兔宝宝发现是大灰狼，一齐将大灰狼赶跑的故事，在讲述中，将Come in,please. Go out.穿插 其中，孩子们对此非常感兴趣，在不知不觉中，竟然全部掌握，且印象极深。又如：在教单词turnip时，我在引入时先说Im a rabbit,Im very hungry,I want some thing to eat.在这个情节引入后，幼儿复习各种已学过的食物单词，教师还是很饿，Imstillhungrynow时，巧妙地出示了食物萝卜引出 新的单词turnip的学习，在老师的引导下引出《拔萝卜》，使幼儿与老师共同参与，自然学习新的知识。 2、情景教学法。 幼儿的语言能力是在实际运用过程中发展起来的，应创设各种有意义真实的情景，使他们想说、会说、喜欢说。语言的'习得与周围环境息息相关。英语的学习是一种自然习得式的学习，而不是一种教学式的学习。语言的学习不只是学习几个单词，更重要的是运用语言和别人交往。因此，教师要以幼儿
说说“卿”字的前世今生
说说“卿”字的前世今生 未 0530 1415 说说“卿”字的前世今生 看电视、看电影，听戏，有皇帝出场的时候总要说几句“爱卿平身”“众卿家……”之类的话，大家也听得耳熟。今天，我们就讲讲“卿”的话题。 我们先来看看“卿”字的构造，《说文解字》说：“卿，章也。六卿：天官冢宰、地官司徒、春官宗伯、夏官司馬、秋官司寇、冬官司空。从，皀声。”皀，音bī，就是“簋”，即古代盛实物的一种容器，圆口，一般是用青铜或陶制称成的，然又以青铜器为主。而，音qīng，从甲骨文和金文上看，就是两个面对面跪坐着的人。“”和“皀”和在一起呢，就是两个人围着簋在吃饭。这是“卿”的本义，即飨食之意，《说文》解释为“章”，不正确。 前几次，我们讲到丞相的“相”，本义是看，后来变成帮助瞽看东西的人，又变成在举行礼仪时帮助主祭者的人，最后变成一种高级官职。而“卿”的演变，与“相”有相通之处。“卿”本义是飨食。大家知道，簋这种青铜器是贵族专用的，能围在簋边上吃饭的，那也得至少是个贵族。后来“卿”就渐渐变成“陪着国君吃饭的人”。 能陪国君吃饭，在古代那可是一项很特殊很尊崇的待遇。就是现在，能陪国家领导人吃饭，那也是一件值得显摆的事儿！《论语?乡党》中说：“君赐食，必正席先尝之；君赐腥，必熟而荐之；君赐生，必畜之。”国君赏赐的食物尚且如此，何况是陪着一起吃饭呢？我们再看看《左传?宣公二年》中的一则资料： 秋九月，晋候饮赵盾酒，伏甲将攻之。其右提弥明知之，趋登，曰：“臣侍君宴，过三爵，非礼也。”遂扶以下。 我们着重看“臣侍君宴，过三爵，非礼也”这一句，赵盾这个晋国的正卿，类似于日本的首相，陪国君宴，喝酒都不能超过三杯，更何况吃饭呢？卿里面的“皀”，也就是“簋”，一般是盛黍、稷这类的主食的，相当于今天的主食米饭。《仪礼·公食礼》就有“宰夫设黍稷六簋”这样的记载。由是可见，卿这种“陪国君吃饭的人”是有很高身份的。 后来，卿也和“相”一样，变成了一种高级官职的名称。《礼记·王制》曰：“诸侯之上大夫卿。”《注》道：“上大夫曰卿。”《礼记·王制》又有：
(完整版)5003-比较文学概论a卷答案
试卷编号：5003 浙江广播电视大学2006年春季学期开放教育本科期末考试《比较文学概论》试题答案及评分标准 2006年7月 一、填空题（每个1分，共15分） 1.垮学科 2.比较文学评论 3.林纾 4.意象 5.原型 6.水平接受 7.新批评派 8. 双向诠释 9.希腊神话 10.抒情、动作 11.《摩罗诗力说》 12.文学理论 13.《拉奥孔──论绘画和诗歌的界限》 14.超媒体 二、判断题。正确的说法后面打“∨”，错误的说法后面打“╳”，并简要说明理由或举例说明。（每个6分，共30分） 1. 比较文学是从世界的角度以文学作为一个整体去追溯文学的发生和演进。（╳） 错误。从世界的角度以文学作为一个整体去追溯文学的发生和演进是总体文学，不是比较文学。比较文学是研究存在于不同文化中的不同文学之间的现象以及其间的各种关系，同时还研究文学与艺术、社会科学、自然科学等诸多方面的联系，跟总体文学既有联系又有区别。 2.“和而不同”是研究比较文学的重要原则。（∨） 正确。“和而不同”中首先是“不同”，没有不同就很难有发展，“和”的主要精神就是协调不同，达到新的和谐统一。这种承认差别，不断追求新的和谐的精神，正是比较文学的精神。比较文学就是一方面要在不同文化的文学里，从诸多差别中，寻求内在的一致，也就是“和”，另一方面，又要从已有的、已然呈现的和谐中，分解出其差别和不同。 3.如果说题旨更依赖于客观的素材，那么，主题则更与作家的主观思想联系在一起。（∨） 正确。题旨是指题材所显示的信号和意义，而题材又是在对素材剪裁的的基础上写入作品的部分，因此题旨与素材的关系密切。而我们通常所说的主题，一方面是作家通过作品提炼出来的，并把作品内容的各个方面组成成一个整体的基本问题；另一方面是作者对这些问题的看法和态度，显然主题与作家的主观思想联系得更密切。 4.中西文论都承认文学有模仿或反映世界，提高人们认识的功能。因此，中西诗学在这方面的认识，应该说取得了完全的一致。（╳） 这种说法不完全正确。尽管中西文论中都承认文学有模仿或反映世界，提高人们认识的
产品策划：创意的六个来源
产品策划：创意的六个来源 产品策划：创意的六个来源 顾客导向的市场营销，关键在于发现并满足顾客的需求，从4p来说就是研发新产品。而怎样才能发现顾客的需求呢？这就需要做市场研究，比如市场调查和市场洞察。 现在的市场竞争激烈，环境变化很快，这样客观要求企业必须对市场做出快速的反应。在这样的情况下企业显然不可能在做每一个营销决策，出每一个产品创意的时候，都会去做市场研究，对中国的中小企业来说，更是如此。 热点推荐： 财运测试大全职场社交六大著名法则解析江湖骗术之十三“枪”
soho创业掘金宝典06风向标哪些行业钱途好北京一个商场工作人员内幕大揭密 既然如此，那在做产品策划的时候，有没有什么方法，是可以在不用做市场研究的前提下，还很可能出好的产品创意呢？ 我想方法还是有的，为此笔者总结了产品策划，常用的六个创意来源，以期能抛砖引玉。 一、模仿跟进 就是竞争对手有什么产品推出市场取得了好的效果，或者说竞争对手有什么新产品经过我们判断将有很好的市场前景，那么我们就研发什么产品推出市场。 这是大家常用的熟悉的方法，可能有很多做产品策划的人员，看不起这种方法，认为这种方法太简单，体现不了策划人员的价值。其实不然，对于企业来说是利润压倒一切，判断一个创意有多大价值，关键在于他为企业创造了多
大的价值，这不是以产品策划人员的意志为转移的，希望产品策划人员务必要有这样的意识。 其实模仿跟进是最经济高效的方法，市场中最常见的成功大都源于此，比如互联网中5460之于chinaren，baidu 之于google，超级女声之于美国偶像，以及传统行业中采乐之于海飞丝，而在近几年兴起的sp行业，源于这种模式的成功案例更是比比皆是。 二、空白区域 这个方法跟模仿跟进有点类似，就是在竞争对手所没有开拓的空白市场区域，推出与竞争对手相同或相似的产品，以抢占市场空白区域，另外空白区域的方法还包括企业内部分公司运用这样的思路在区域市场上运作企业样板市场被证明过的产品或模式。 空白区域的方法的运用需要企业具备敏锐的市场触角、宽广的视野、快速行动的能力。 为什么这样说呢？一般来说，空白
音乐的前世今生
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描写前世今生的抒情散文
描写前世今生的抒情散文 如果存在前生和来世，洛阳有牡丹盛开，济南有荷花凋谢，我们前生和来世的家在哪里? 下文是为大家推荐的描写前世今生的抒情散文，欢迎大家参考。 描写前世今生的抒情散文 我的前世可能是一根原地寂寞旋转的秒针，一生忙忙碌碌却孤独终老。 我的前世可能是满腹心事的宋代女词人在深夜轻吟浅唱所用的丝竹，平平淡淡丝丝缕缕的美好。 我的前世可能是沙滩濒死的贝壳，被无数炽热的沙粒包裹，里面却珍藏着一颗剔透晶莹的珍珠，到死也无法展露人世，无人问津。 我的前世可能是一只无脚的飞鸟，即使一生沿途风光大好，也不能为此停留，一直倔强而顽强的飞行，无休无止，只能在死前闭一次眼，心安理得的歇息最后一次。 我的前世可能是一袭华贵的红袍见证无数痴情的女子在无尽的等待中化为灰烬，或者等来明媚的幸福，十里红妆，白头偕老。 我的前世可能是邪恶巫婆手中美味的毒苹果;我的前世可能是稍纵即逝的烟火;我的前世可能是佛前虔诚的烛光，我的前世可能是人鱼的一粒眼泪。 前世今生，物是人非;千年一梦，再无瓜葛。
无论前世的我如何精致，我深知，今生今世，我不过只是一个会在深夜以某种孤寂的姿势仰望天空的平凡的孩子。 平凡到会因为一场考试而感到别样的伤感。 尽管老师一再强调时间观念，我也没有不到一丝一毫的紧迫感。 半期考试的时间逐渐逼近，四分之一的初二生活已在季节更换的罅隙里丢下迷茫的我，轰轰烈烈的奔远了，前方是一片未知弥漫的满天迷雾，晃花了眼，搅乱了心。 我可以清晰的感受到自己以往一向极其珍视的名次以不亚于星子陨落的速度下坠。 D说，这极度夸张。 不过，平心而论，自己成绩下滑幅度的确过大。 曾经不止一次深刻反省过这类问题，若究其缘由，大抵同我上课看小说有着密不可分的联系。 我的理智不厌其烦的提醒我，这是错误的。 D还说过，你说话做事从来不经过大脑，不考虑后果，只会一昧的道歉。 当时他一本正经的模样，就算去桥头戴上墨镜为人算命，我想也会有人掏钱，十足的江湖术士气息。 迄今为止，我终究还是不能达到心平气和，波澜不惊的境界。 我是个意志力薄弱的人，在我单薄的青春里，我没有半途而废的事情屈指可数。 比如，此刻。
(完整版)《比较文学概论》试题(一)
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幼师英语教案
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Teachi ng Summ ary Through this unit learning,students can understand the preschool education.Students can write down the right answers by repeatly listening.They can speak the dialogue fluently.Can read the text and understand the meaning .