{
  "url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-8/division-8.3/division-5",
  "json_url": "https://openlegislation.uk/eu-directive-2004-10/annex-I/section-II/division-8/division-8.3/division-5.json",
  "legislation": "eudr/2004/10",
  "legislation_title": "Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-10",
  "path": "annex/I/section/II/division/8/division/8.3/division/5",
  "kind": "division",
  "number": "5",
  "heading": null,
  "text": "Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/10/annex/I/section/II/division/8/division/8.3/division/5",
    "retrieved_at": "2026-11-01T15:22:51.082187+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}