{ "name": "Sopvo Written Procedure Requirements", "title": "Written Procedure Requirements", "url": "https://sopvo.com/datasets/written-procedure-requirements/", "csv": "https://sopvo.com/datasets/written-procedure-requirements.csv", "markdown": "https://sopvo.com/datasets/written-procedure-requirements/index.md", "computed_at": "2026-09-15", "license": "https://sopvo.com/terms", "headline": "The Written Procedure Requirements carries 1 published figure read from 2 sources' own pages, from 4 to 4 week, read 15 September 2026.", "quotes": [ "The Written Procedure Requirements carries 1 published figure read from 2 sources' own pages, from 4 to 4 week, read 15 September 2026.", "2 of the 13 named sources read in full publish a figure; 11 publish none, read 15 September 2026." ], "citation": "\"Sopvo Written Procedure Requirements\", updated 2026-09-15, https://sopvo.com/datasets/written-procedure-requirements/.", "changed_since": null, "national": { "unit": "week", "n": 1, "median": 4, "min": 4, "max": 4, "p25": 4, "p75": 4, "mean": 4, "units": { "day": 1, "hour": 1, "week": 1 }, "published_sources": 2, "named_sources": 13, "read_sources": 13, "not_published": 11, "published_share": 0.154 }, "by_axis": {}, "rows": [ { "source": "eCFR: 21 CFR Part 58 - Good Laboratory Practice, standard operating procedures", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58", "figure": "4 weeks", "value": 4, "unit": "week", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(d) For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by ยง 58.195.", "source_class": "primary-government", "text_sha256": "49d3466cb29652a3db947a888624cbedf90e402b6f0eef7e461a91e1f3683e95" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "24 hours", "value": 24, "unit": "hour", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(ii) After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law must see and assess the patient.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "1 hour", "value": 1, "unit": "hour", "axis": {}, "retrieved_at": "2026-09-12", "quote": "At a minimum, physicians and other licensed practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion. (12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the pat", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "30 days", "value": 30, "unit": "day", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(i) A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(5)(iii) of this section.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "30 days", "value": 30, "unit": "day", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(A) A medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(4)(i)(C) of this section.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "24 hours", "value": 24, "unit": "hour", "axis": {}, "retrieved_at": "2026-09-12", "quote": "The medical history and physical examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "30 days", "value": 30, "unit": "day", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(B) An updated examination of the patient, including any changes in the patient's condition, when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (c)(4)(i)(C) of this section.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "24 hours", "value": 24, "unit": "hour", "axis": {}, "retrieved_at": "2026-09-12", "quote": "Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "30 days", "value": 30, "unit": "day", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(viii) Final diagnosis with completion of medical records within 30 days following discharge.", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" }, { "source": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "figure": "45 days", "value": 45, "unit": "day", "axis": {}, "retrieved_at": "2026-09-12", "quote": "(ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; and", "source_class": "primary-government", "text_sha256": "032a257543375af0937e4ce3fa98b7ea25ba8bbcc7afdf6a6bb93a9b0f157e13" } ], "not_published": [ { "source": "eCFR: 21 CFR 211.100 - Written procedures; deviations", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR: 21 CFR Part 820 - Quality System Regulation", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR: 21 CFR Part 11 - Electronic records; electronic signatures", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11", "retrieved_at": "2026-09-11", "reason": "read in full and no accepted figure on the page" }, { "source": "eCFR: 45 CFR 164.316 - Policies and procedures and documentation requirements", "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C/section-164.316", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "HHS: Summary of the HIPAA Security Rule", "url": "https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html", "retrieved_at": "2026-09-11", "reason": "read in full and no accepted figure on the page" }, { "source": "OSHA: 1910.1200 Hazard Communication", "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "NIST SP 800-53 Rev. 5 (security and privacy controls)", "url": "https://csrc.nist.gov/pubs/sp/800/53/r5/upd1/final", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "ISO 9001:2015 (catalogue record)", "url": "https://www.iso.org/standard/62085.html", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "ISO 13485:2016 (catalogue record)", "url": "https://www.iso.org/standard/59752.html", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" }, { "source": "ISO/IEC 27001 (catalogue record)", "url": "https://www.iso.org/standard/27001", "retrieved_at": "2026-09-11", "reason": "read in full and no accepted figure on the page" }, { "source": "ecfr.gov", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "retrieved_at": "2026-09-12", "reason": "read in full and no accepted figure on the page" } ], "sources": [ { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "label": "eCFR: 21 CFR 211.100 - Written procedures; deviations", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", "label": "eCFR: 21 CFR Part 820 - Quality System Regulation", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11", "label": "eCFR: 21 CFR Part 11 - Electronic records; electronic signatures", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58", "label": "eCFR: 21 CFR Part 58 - Good Laboratory Practice, standard operating procedures", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C/section-164.316", "label": "eCFR: 45 CFR 164.316 - Policies and procedures and documentation requirements", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html", "label": "HHS: Summary of the HIPAA Security Rule", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482", "label": "eCFR: 42 CFR Part 482 - Conditions of Participation for Hospitals", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200", "label": "OSHA: 1910.1200 Hazard Communication", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://csrc.nist.gov/pubs/sp/800/53/r5/upd1/final", "label": "NIST SP 800-53 Rev. 5 (security and privacy controls)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.iso.org/standard/62085.html", "label": "ISO 9001:2015 (catalogue record)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.iso.org/standard/59752.html", "label": "ISO 13485:2016 (catalogue record)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.iso.org/standard/27001", "label": "ISO/IEC 27001 (catalogue record)", "license": "the publisher's own terms; quoted for reporting and comment" }, { "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100", "label": "ecfr.gov", "license": "the publisher's own terms; quoted for reporting and comment" } ], "methodology": "Every row is a verbatim sentence read from the named source's own page through the estate's fetch service on the date shown, hash-pinned to the stored read (the sha of the page's visible text; the raw page is mirrored to R2). 2 of the 13 named sources that could be read published a usable figure; 11 published none and are recorded as not published, never filled in; 0 could not be read (blocked, dead or unreachable) and count nowhere. The headline figures (median, minimum, maximum, quartiles) are over ONE figure per source in week (a source's median where its page yielded several accepted sentences), so N counts sources, never sentences; 4 candidate sentence(s) were refused by a reviewer with the reason recorded. Derivation as chartered: one row per regime per obligation, quoted verbatim from the authority with its citation and effective date: what must be written, who must approve it, how deviations are handled, how long it is retained, and whether the electronic record is itself regulated. The figure across the set is the comparison nobody publishes: the retention period, the approval requirement and the deviation rule side by side across FDA GMP, the Quality System Regulation, Part 11, GLP, the HIPAA Security Rule, the CMS hospital conditions of participation, ISO 9001, ISO 13485, ISO 27001 and NIST SP 800-53 - so a reader can see that HIPAA sets six years and 21 CFR 211 sets an approval chain, and which of the ten regimes their own SOP has to satisfy at once. Changed-since on every read.", "embed": "

4 to 4 week

1 published figures, Written Procedure Requirements, across 2 sources, read 15 September 2026

Source: Sopvo Written Procedure Requirements
" }