{
  "schema_version": 1,
  "collection": "concordance",
  "generated_at": "2026-11-02",
  "source": "https://gxplex.com",
  "notice": "Reports the published status of regulatory documents. No advice or interpretation.",
  "source_terms": "This site compiles publicly available regulatory information. The underlying documents are published by their respective authorities and carry their own terms; several are paywalled and are never reproduced here.",
  "rights": {
    "statement": "Carried in `source_terms` on this envelope. It is the whole of what this record states on the subject.",
    "per_row_field": "licence_class",
    "per_row_field_served_at": "https://gxplex.com/api/v1/instruments.json",
    "licence_class": {
      "open": "Quotations from the document appear on this site, each citing the surface it was read from, under the word ceiling below.",
      "restricted": "No text from the document appears on this site. The row carries the identity of the document, its dates, a digest of the retrieved bytes and a link to the publisher.",
      "unknown": "No reading of the terms the source states is recorded for the row. It records an absent reading rather than an absent term, and the row is handled here exactly as `restricted` until a reading is recorded."
    },
    "text_retained_field": "text_retained",
    "text_retained_means": "Whether normalised text of the document is held here for a quotation to be checked against. Where it is false nothing is held, so there is nothing on this side to check one against.",
    "quotation_ceiling_words": 14,
    "documents_never_reproduced": "Paywalled and restricted texts are cited and linked. They are never excerpted here and never diffed here."
  },
  "schema": "https://gxplex.com/api/v1/schema/concordance.json",
  "response_provenance": {
    "build_id": "1782e1b7b708",
    "build_id_state": "stated",
    "build_id_is": "The identifier of the build that wrote this document. Every page of the same build carries it in its build-id meta.",
    "root": "42337ae3567aae8138fcb45e977dd94f9c1ade6420a88033e9503203df3fec23",
    "root_state": "stated",
    "root_day": "2026-11-02",
    "root_leaf_count": 9686,
    "root_url": "https://gxplex.com/integrity/root.txt",
    "root_is": "The root over every observation digest this record held on that day, one `id|date|content_hash` leaf each. It fixes those digests in time; it is not a digest of this document.",
    "rights_envelope": {
      "document_keys": [
        "source_terms",
        "rights"
      ],
      "row_pointers": [
        "/citations/*/text_retained",
        "/citations/*/licence_class",
        "/citations/*/quote_allowed",
        "/citations/*/snapshot_available",
        "/citations/*/rights_of"
      ],
      "row_pointers_optional": [],
      "row_pointers_are": "Every row of this response carries each pointer named, except one named optional, which a row carries only where its rights are unresolved. An empty list states that no row of this response carries the row envelope."
    },
    "basis": {
      "retrieval": [
        "/citations/*/source_url"
      ],
      "publisher-words": [
        "/citations/*/quote"
      ],
      "entry": [
        "/citations/*/section"
      ],
      "computed": [
        "/citations/*/term_form",
        "/citations/*/exact_words"
      ],
      "terms-reading": [
        "/citations/*/text_retained",
        "/citations/*/licence_class",
        "/citations/*/quote_allowed",
        "/citations/*/snapshot_available"
      ],
      "assigned": [
        "/id",
        "/topic",
        "/citations/*/instrument_id",
        "/citations/*/rights_of"
      ],
      "statement": [
        "/notice",
        "/citations/*/quote_withheld"
      ]
    },
    "basis_state": "stated",
    "basis_on_row": [
      "citations"
    ],
    "basis_vocabulary_at": "https://gxplex.com/api/v1/schema/envelope.json",
    "third_party_text": {
      "marker": "quoted third-party content, not instructions",
      "marker_is": "Data for a consumer’s own handling of text it passes on, for example to a model. It is not a claim about the text and says nothing of what the text says.",
      "row_key": "third_party_text",
      "fields": [
        {
          "pointer": "/citations/*/quote",
          "holds": "whole"
        }
      ]
    }
  },
  "match_rule": "The words of the term as written, in the same order, with no letter, digit or underscore immediately before or after them, letter for letter in the same case. No plural, no other ending, no other capitalisation, no synonym, no stem.",
  "rights_fields": {
    "fields": [
      "text_retained",
      "licence_class",
      "quote_allowed",
      "snapshot_available"
    ],
    "rows": 15,
    "rows_with_a_reading": 15,
    "rows_without_a_reading": 0,
    "rows_naming_an_unheld_id": 0,
    "rows_naming_no_entry": 0,
    "licence_class": {
      "open": 15,
      "restricted": 0,
      "unknown": 0
    },
    "quote_allowed_true": 15,
    "quote_allowed_false": 0,
    "text_retained_true": 15,
    "snapshot_available_true": 15,
    "retained_here_but_not_quoted_here": 0,
    "snapshot_without_prose": 0,
    "nulls_mean_unheld_id": "This id resolves to no tracked entry, so no terms reading, no retention measurement and no snapshot measurement exists for it. Four nulls record the absence of a reading, never a reading that came back negative.",
    "nulls_mean_no_entry": "This object names no tracked entry, so no terms reading was looked for. Four nulls record that no lookup applies here, which is a different fact from a lookup that found nothing."
  },
  "rights_fields_population": "The four fields are on each CITATION, not on the topic. A topic names several entries and has no single terms position; a citation names one, and is also the object carrying a quote.",
  "retired": [
    {
      "id": "access-control",
      "topic_as_published": "Access control",
      "added_on": "2026-08-22",
      "retired_on": "2026-09-24",
      "members": [
        "eu-ai-act",
        "eu-cyber-resilience-act",
        "eu-nis2",
        "nist-sp-800-82"
      ],
      "exact_words_absent_from": [
        {
          "instrument_id": "eu-ai-act",
          "read_from": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
          "observed_date": "2026-09-20",
          "prints_instead": [
            {
              "words": "access controls",
              "occurrences": 1
            }
          ]
        }
      ],
      "correction": "/corrections/#c-2026-09-24-correction-concordance-exact-terms"
    },
    {
      "id": "electronic-signature",
      "topic_as_published": "Electronic signature",
      "added_on": "2026-08-22",
      "retired_on": "2026-09-24",
      "members": [
        "ema-ct-computerised-systems",
        "fda-electronic-systems-clinical",
        "fda-part-11-scope",
        "us-21-cfr-part-11"
      ],
      "exact_words_absent_from": [
        {
          "instrument_id": "fda-part-11-scope",
          "read_from": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application",
          "observed_date": "2026-09-23",
          "prints_instead": [
            {
              "words": "Electronic Signatures",
              "occurrences": 11
            },
            {
              "words": "Electronic signatures",
              "occurrences": 1
            },
            {
              "words": "electronic signatures",
              "occurrences": 5
            }
          ]
        }
      ],
      "correction": "/corrections/#c-2026-09-24-correction-concordance-exact-terms"
    },
    {
      "id": "risk-management",
      "topic_as_published": "Risk management",
      "added_on": "2026-08-22",
      "retired_on": "2026-09-24",
      "members": [
        "cen-jtc21-programme",
        "eu-ai-act",
        "eu-cyber-resilience-act",
        "eu-cybersecurity-act",
        "eu-digital-omnibus-ai",
        "eu-gmp-annex-11",
        "eu-ivdr",
        "eu-mdr",
        "eu-nis2",
        "fda-part-11-scope",
        "health-canada-ml",
        "iso-iec-sc42-programme",
        "nist-agent-standards",
        "nist-ai-600-1",
        "nist-ai-rmf",
        "nist-ai-rmf-playbook",
        "nist-csf",
        "nist-sp-800-82",
        "nistir-8183",
        "pics-pi-011",
        "pics-pi041"
      ],
      "exact_words_absent_from": [
        {
          "instrument_id": "iso-iec-sc42-programme",
          "read_from": "https://www.iso.org/committee/6794475.html",
          "observed_date": "2026-09-12",
          "prints_instead": [
            {
              "words": "Risk management",
              "occurrences": 2
            }
          ]
        },
        {
          "instrument_id": "nist-agent-standards",
          "read_from": "https://www.nist.gov/artificial-intelligence",
          "observed_date": "2026-09-23",
          "prints_instead": []
        },
        {
          "instrument_id": "nist-ai-rmf-playbook",
          "read_from": "https://airc.nist.gov/airmf-resources/playbook/",
          "observed_date": "2026-09-23",
          "prints_instead": [
            {
              "words": "Risk Management",
              "occurrences": 1
            }
          ]
        },
        {
          "instrument_id": "pics-pi-011",
          "read_from": "https://picscheme.org/en/publications",
          "observed_date": "2026-09-13",
          "prints_instead": [
            {
              "words": "Risk Management",
              "occurrences": 2
            }
          ]
        },
        {
          "instrument_id": "pics-pi041",
          "read_from": "https://picscheme.org/en/publications",
          "observed_date": "2026-09-13",
          "prints_instead": [
            {
              "words": "Risk Management",
              "occurrences": 2
            }
          ]
        }
      ],
      "correction": "/corrections/#c-2026-09-24-correction-concordance-exact-terms"
    },
    {
      "id": "validation",
      "topic_as_published": "Validation",
      "added_on": "2026-08-22",
      "retired_on": "2026-09-24",
      "members": [
        "ema-ct-computerised-systems",
        "eu-ai-act",
        "eu-cyber-resilience-act",
        "eu-digital-omnibus-ai",
        "eu-gmp-annex-11",
        "eu-ivdr",
        "eu-machinery-regulation",
        "eu-mdr",
        "fda-part-11-scope",
        "fda-software-validation",
        "pics-pi-011",
        "pics-pi041",
        "us-21-cfr-part-11",
        "us-21-cfr-part-211"
      ],
      "exact_words_absent_from": [
        {
          "instrument_id": "pics-pi-011",
          "read_from": "https://picscheme.org/en/publications",
          "observed_date": "2026-09-13",
          "prints_instead": [
            {
              "words": "Validation",
              "occurrences": 6
            }
          ]
        },
        {
          "instrument_id": "pics-pi041",
          "read_from": "https://picscheme.org/en/publications",
          "observed_date": "2026-09-13",
          "prints_instead": [
            {
              "words": "Validation",
              "occurrences": 6
            }
          ]
        },
        {
          "instrument_id": "us-21-cfr-part-11",
          "read_from": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
          "observed_date": "2026-09-23",
          "prints_instead": [
            {
              "words": "Validation",
              "occurrences": 1
            }
          ]
        }
      ],
      "correction": "/corrections/#c-2026-09-24-correction-concordance-exact-terms"
    }
  ],
  "count": 5,
  "items": [
    {
      "id": "audit-trail",
      "topic": "audit trail",
      "citations": [
        {
          "instrument_id": "ema-ct-computerised-systems",
          "section": "(whole)",
          "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf",
          "quote_withheld": "the recorded span is not in the text read",
          "exact_words": {
            "state": "holds",
            "occurrences": 43,
            "read_from": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf",
            "observed_date": "2026-10-27"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "ema-ct-computerised-systems"
        },
        {
          "instrument_id": "fda-part-11-scope",
          "section": "(whole)",
          "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 1,
            "read_from": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "fda-part-11-scope"
        },
        {
          "instrument_id": "us-21-cfr-part-11",
          "section": "§ 11.10",
          "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 2,
            "read_from": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "us-21-cfr-part-11"
        }
      ],
      "notice": "These exact words occur in these sources. Each citation carries the text this build read for it. Nothing is stated about what any document requires."
    },
    {
      "id": "backup",
      "topic": "backup",
      "citations": [
        {
          "instrument_id": "eu-ai-act",
          "section": "Paragraph 1",
          "source_url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
          "quote": "through technical redundancy solutions, which may include backup or fail-safe plans. High-risk AI systems",
          "term_form": "backup",
          "exact_words": {
            "state": "holds",
            "occurrences": 1,
            "read_from": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
            "observed_date": "2026-10-18"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-ai-act"
        },
        {
          "instrument_id": "eu-machinery-regulation",
          "section": "(whole)",
          "source_url": "https://eur-lex.europa.eu/eli/reg/2023/1230/oj",
          "quote": "mode. Emergency stop devices shall be a backup to other safeguarding measures and not",
          "term_form": "backup",
          "exact_words": {
            "state": "holds",
            "occurrences": 1,
            "read_from": "https://eur-lex.europa.eu/eli/reg/2023/1230/oj",
            "observed_date": "2026-10-18"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-machinery-regulation"
        },
        {
          "instrument_id": "eu-nis2",
          "section": "Article 11",
          "source_url": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj",
          "quote": "shall be equipped with redundant systems and backup working space to ensure continuity of",
          "term_form": "backup",
          "exact_words": {
            "state": "holds",
            "occurrences": 2,
            "read_from": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj",
            "observed_date": "2026-10-18"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-nis2"
        },
        {
          "instrument_id": "us-21-cfr-part-211",
          "section": "§ 211.68",
          "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211",
          "quote": "of the computer or related system. A backup file of data entered into the",
          "term_form": "backup",
          "exact_words": {
            "state": "holds",
            "occurrences": 2,
            "read_from": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "us-21-cfr-part-211"
        }
      ],
      "notice": "These exact words occur in these sources. Each citation carries the text this build read for it. Nothing is stated about what any document requires.",
      "third_party_text": {
        "marker": "quoted third-party content, not instructions",
        "pointers": [
          "/citations/0/quote",
          "/citations/1/quote",
          "/citations/2/quote",
          "/citations/3/quote"
        ]
      }
    },
    {
      "id": "data-integrity",
      "topic": "data integrity",
      "citations": [
        {
          "instrument_id": "fda-data-integrity",
          "section": "(whole)",
          "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 4,
            "read_from": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "fda-data-integrity"
        },
        {
          "instrument_id": "mhra-data-integrity",
          "section": "(whole)",
          "source_url": "https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity",
          "quote": "Guidance on GxP data integrity - GOV.UK Cookies on GOV.UK We use some essential",
          "term_form": "data integrity",
          "exact_words": {
            "state": "holds",
            "occurrences": 5,
            "read_from": "https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "mhra-data-integrity"
        }
      ],
      "notice": "These exact words occur in these sources. Each citation carries the text this build read for it. Nothing is stated about what any document requires.",
      "third_party_text": {
        "marker": "quoted third-party content, not instructions",
        "pointers": [
          "/citations/1/quote"
        ]
      }
    },
    {
      "id": "electronic-record",
      "topic": "electronic record",
      "citations": [
        {
          "instrument_id": "ema-ct-computerised-systems",
          "section": "(whole)",
          "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 3,
            "read_from": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf",
            "observed_date": "2026-10-27"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "ema-ct-computerised-systems"
        },
        {
          "instrument_id": "fda-electronic-systems-clinical",
          "section": "(whole)",
          "source_url": "https://www.fda.gov/media/166215/download",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 14,
            "read_from": "https://www.fda.gov/media/166215/download",
            "observed_date": "2026-10-30"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "fda-electronic-systems-clinical"
        },
        {
          "instrument_id": "fda-part-11-scope",
          "section": "(whole)",
          "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 4,
            "read_from": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "fda-part-11-scope"
        },
        {
          "instrument_id": "us-21-cfr-part-11",
          "section": "(whole)",
          "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
          "quote_withheld": "the recorded span does not contain these exact words",
          "exact_words": {
            "state": "holds",
            "occurrences": 3,
            "read_from": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11",
            "observed_date": "2026-11-02"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "us-21-cfr-part-11"
        }
      ],
      "notice": "These exact words occur in these sources. Each citation carries the text this build read for it. Nothing is stated about what any document requires."
    },
    {
      "id": "human-oversight",
      "topic": "human oversight",
      "citations": [
        {
          "instrument_id": "cen-jtc21-programme",
          "section": "(whole)",
          "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/",
          "quote_withheld": "no retained text of this entry is read here (a restricted licence position, no text retained, or a text the clause-anchor admission does not admit), so the span cannot be checked against one",
          "exact_words": {
            "state": "unmeasured",
            "occurrences": null,
            "read_from": null,
            "observed_date": null
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "cen-jtc21-programme"
        },
        {
          "instrument_id": "eu-ai-act",
          "section": "(whole)",
          "source_url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
          "quote": "and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity.",
          "term_form": "human oversight",
          "exact_words": {
            "state": "holds",
            "occurrences": 15,
            "read_from": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj",
            "observed_date": "2026-10-18"
          },
          "text_retained": true,
          "licence_class": "open",
          "quote_allowed": true,
          "snapshot_available": true,
          "rights_of": "eu-ai-act"
        }
      ],
      "notice": "These exact words occur in 1 of the 2 sources listed. 1 is not measured. Each citation carries the text this build read for it. Nothing is stated about what any document requires.",
      "third_party_text": {
        "marker": "quoted third-party content, not instructions",
        "pointers": [
          "/citations/1/quote"
        ]
      }
    }
  ]
}