Commercial Archives: Advantages, Disadvantages and Risks

Transcription

1 Tim Stiles Presentation title Commercial Archives: Advantages, Disadvantages and Risks 1

2 Scope There 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. 2

3 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, 3

4 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. 4

5 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 GxP Archive Document warehouses General and self storage 5

6 General and Self Storage Advantage General and self storage Short contract Cheap? 6

7 Disadvantage General and self storage 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 7

8 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 Advantages Document Warehouse Cost effective! Could be nation wide or global 8

9 Disadvantages Document Warehouse 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 9

10 Advantages GxP Archives 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 Disadvantages GxP Contract Archives Cost? Beware of hidden costs 10

11 Assessing Options Given the three classifications how should we assess these options. Basic Elements in Assessment (Risk) Fire Archive Storage area Environment Conditions 11

12 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 12

13 Fire, response Fire response, not water 13

14 Basic Elements in Assessment (Risk) Fire Archive Storage area Environment 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 14

15 Archive in the basement Water damage 15

16 Archive area Controlled Access 16

17 Basic Elements in Assessment (Risk) Fire Archive Storage area Environment 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 17

18 Pest Prevention 18

19 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 19

20 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 20

21 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 Compliance Is 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 21

22 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 22