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23/06/2014 1 Tim Stiles www.qualogy.co.uk Presentation title Commercial Archives: Advantages, Disadvantages and Risks

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Page 1: Commercial Archives Advantages, Disadvantages …...Advantages, Disadvantages and Risks 23/06/2014 2 Scope There can be many different reasons why you may consider the need to use

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Tim Stiles www.qualogy.co.uk

Presentation title

Commercial Archives: Advantages, Disadvantages

and Risks

Page 2: Commercial Archives Advantages, Disadvantages …...Advantages, Disadvantages and Risks 23/06/2014 2 Scope There can be many different reasons why you may consider the need to use

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ScopeThere can be many different reasons why you may consider

the need to use a contract archive.

This presentation examines some of those options and the

Advantages, Disadvantages and risks.

Archive….what do the GLPs require?

• GLP requires that:

Archive should be provided for the secure storage and retrieval of study plans, final reports, raw data, samples of test items and specimens.

Archive design and archive conditions should protect the contents from untimely deterioration or loss.

An individual is identified as being responsible for management of the archives.

Very similar requirements in GCP/GMP….

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OECD. Monograph No.15.Establishing and Control of Archives that

Operate in Compliance with the Principles of GLP

GLP require that a test facility has an archive but the use of contract archive facilities is not precluded. In this situation, the guidance contained within this document should equally apply to the contract archive facilities

The following factors need to be considered when using contract archive facilities:

• 10.1 Contracts and/or Service Level Agreements

• A formal agreement that details:– the level and conditions of service to be provided.– description of the records and materials to be archived– chain of custody records and materials to the archive– access to stored records and materials – storage conditions, duration of storage, method of

retrieval/access and method of return/disposal– The contract archive should have and follow relevant SOPs,

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The following factors need to be considered when using contract archive facilities:

• 10.2 Access Arrangements• Procedures should define how, and when,

stored records and/or materials can be accessed by the depositor of the records and/or materials. Any such access should be approved and documented.

The following factors need to be considered when using contract archive facilities:

• 10.3 Conditions of Storage• The conditions of storage and the procedures

followed should be the same standard as those expected of a test facility archive which is operated in compliance with GLP.

• Appointment of a suitably qualified archivist• SOPs describing archiving activities • Provision of suitable storage areas to prevent

deterioration or loss of materials.

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The following factors need to be considered when using contract archive facilities:

• 10.4 Inspections• Periodically the contract archive facility should

be inspected by Quality Assurance from or on behalf of the test facility or the sponsor.

• To ensure that the conditions of the service level agreement are being met and that the systems and procedures operated by the contract archive facility comply with their SOPs and the Principles of GLP.

Archive Options Classification

GxPArchive

Document warehouses

General and self storage

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General and Self Storage

General and self storage

• Advantage– Short contract– Cheap?

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General and self storage

• Disadvantage– A room surrounded by other rooms– No control of other units around yours– Not limited access– Not regulatory compliant– Environmental conditions not controlled– Higher risk of loss or damage– etc

Self Storage Facility

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Document Warehouse

• Store any records• Often many hundreds of clients with different

needs and expectations• Little or no awareness of regulatory

requirements• Will move material to maximise space• Will mix client material to “fill” gaps• “They are only old records”

Document Warehouse

• Advantages– Cost effective!– Could be nation wide or global

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Document Warehouse

• Disadvantages– Not regulatory compliant– Security can be questioned– Difficulty in meeting individual client needs– You have to fit within their systems– You could be 1 of their 1000’s of clients– Dispersion of your material on site and between

sites– Uncontrolled storage conditions

GxP Regulatory Archive

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GxP Archives

• Advantages– Regulatory compliant– Supports your compliance status– Focused on individual client needs– Quality Management system (SOPs etc)– Take better care of your data– Understand your business needs– Archivist with knowledge of GxP requirements– Cheaper than leaving at CRO

GxP Contract Archives

• Disadvantages– Cost?– Beware of hidden costs

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Assessing Options

Given the three classifications how should we assess these

options.

Basic Elements in Assessment (Risk)

Fire

Archive Storage areaEnvironment Conditions

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Fire prevention

• First step is to minimize risk– Stand alone building– Minimal flash points for a fire to start

• Detection– Fire alarm system– Linked to notification system for response

• Fire response– Suppression system

Fire, detection

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Fire, response

Fire response, not water

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Basic Elements in Assessment (Risk)

Fire

Archive Storage areaEnvironment Conditions

Archive area

• Secure authorised access to archive• Orderly storage not dispersed around archive• Prevent loss or damage to archived material• Compliant with regulatory expectation (SOPs)• Material off the walls and floor• Access to archived material - retrievable• Boxes not overly stacked• Adequate space

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Archive in the basement

Water damage

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Archive area

Controlled Access

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Basic Elements in Assessment (Risk)

Fire

Archive Storage areaEnvironment Conditions

Environment Conditions

• Conditions set to ensure protection of material stored.

• Continuously monitored for temperature and humidity

• Automated monitoring and alarm• Response to out or range conditions• Pest prevention programme

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Pest Prevention

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Claims made

Quality Management System QMS

• Defined standards, GxP, SOPs• Evidence of compliance with GxP standards• Quality Control• Chain of custody• Alarm systems• Equipment maintenance• Training records

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Advantages of Contract Archives

• Provision of additional archive storage• Cheaper than in-house expansion• Centralise data from a CRO• Secure retention of Investigator site files• Provision of GxP Compliance• Independent• Knowing where your data is located

Disadvantages of Contract Archives

• Needs to be audited

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Risks

• Selecting the right/wrong vendor• Archiving is perceived by Management to be

low risk• Under estimating the value of your data• Doing nothing• Not knowing where your data is• Relying on the Principal Investigator

Risk - Regulatory ComplianceIs the operation aware of the requirements of the

Regulations.Does the operation comply with the Good

Laboratory and Good Clinical Practice. Beware of false claims (GxP, BSI, ISO)

Does the provider meet your business needs

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Summary• Is biggest best ?• Risk, many of you run your own archives to

defined standards, the commercial archive should meet or exceed those standards.

• Costs, beware of the hidden costs• The business needs in terms of protection,

reduced risk and regulatory compliance should be fulfilled.

• Centralisation of data from CRO or Investigator