On behalf of Hedwig Beernaert, NUBEL

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QMS for data systems (computer systems)

• On behalf of Hedwig Beernaert, NUBEL
• Anders Møller
• Danish Food Information
• Roskilde, Denmark

EuroFIR Compiler Network Meeting, Paris, March
2007
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Quality Assurance Issues for Computerized Systems

• Limit requirements to a set minimum of
• minimum requirements
• Network configuration of FCDBs
• Software development and application
• Security aspects
• List of required Standard Operating Procedures
  (SOPs)
• The necessity for contingency plans
• Back ups and archives
• Responsibilities

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EuroFIR Network configuration of FCDBs
Where are the servers and who is
responsible? Validation of accuracy of transfer?
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FCDBMs Software Development and Use

• Is the software validated and documented?is it
  documented? delivered by ISO9001 supplier?
  source code available?
• Acceptance according to EuroFIR criteria?
• Retrospective evaluation is the system
  documented?
• Change control? - changes in hard or software
  documented?
• Controls to ensure good functionality?

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Security Aspects

• Physical access documented?
• Logical security authorised access?
• Data integrity who has access to data?
• Backup who is doing it? how often?
• Contingency plans ?

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Contingency Plans

• It is recommended that each compiler documents
  the contingency plan used in the case of a
  failure of its system. Maintenance contracts with
  the supplier, back up procedures or the
  availability of a central system are
  possibilities which can ensure the integrity of
  the data in the FCDB.A discussion and decision
  should be taken at the following EuroFIR meeting
  of WP 1.3.

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List of Standard Operating Procedures

• Policies
• Application description
• Source code
• Standard Operation Procedures (SOP) which
  should be described by whom and when?

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Back up systems and Archiving

• It is important that the back up system to be
  used by the compilers are discussed at the next
  EuroFIR meeting of WP 1.3 and that a consensus be
  achieved about the frequency of back ups, the
  storage medium and time period of archiving.

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Responsibilities

• Local and central compilers prepare a list with
  the coordinates of the persons responsible for
  the management of the FCDB and the server.
• EuroFIR installs an organization charged with the
  verification of the compilers system to ensure
  that they respond to the EuroFIR requirements.
• EuroFIR designates an organization having the
  knowledge and experience of FCDMBs which can set
  up with the actual existing hardware and software
  systems a coherent network system and organize
  training courses

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Thank you for your patience

• Anders Møller
• am_at_danfood.info