GxPlex

Evidence packet — 21 CFR Part 820 (QMSR)

One row of this record, assembled so it can be taken somewhere else: what the publisher published, where this record read it, what it hashed, and what changed between two readings it retained. Generated 2026-09-18. It carries no assessment of what the document requires and no reading of what any change means.

The packet, in three formats

Each is the same object. /packet/us-21-cfr-part-820.json carries every field; /packet/us-21-cfr-part-820.md is the same content as plain text; and /packet/us-21-cfr-part-820.zip is an archive of those two together with this row’s slice of the published leaf file and the published root. Every byte in the archive is served at its own address as well; it originates nothing.

Source

Identity as this record holds it for 21 CFR Part 820 (QMSR)
FieldValue
Identifier us-21-cfr-part-820
Title 21 CFR Part 820 — Quality Management System Regulation
Jurisdiction US
Address requested https://www.ecfr.gov/current/title-21/part-820
Address answered
Observed cadence monthly
Row /r/us-21-cfr-part-820

The address a request ANSWERED at is this record’s address for the row. The address it aimed at is testimony and is carried beside it, because a redirect is a publisher’s own statement about what supersedes what.

Publisher

The body, and the origin that answered
FieldValue
Authority US Food and Drug Administration
Origin host
Origin read from
Standards body
Standards body read from

No origin host is recorded for this row. The authority named above is the body; the host is a fact about which origin answered, and this row does not carry one.

Type

The class the publisher states, and the kind of record this is
FieldValue
Class, as the publisher states it
Read from
Source kind, recorded here document
Source type, recorded here document
Record tier core

No class statement by the publisher is recorded for this row, so this packet states none. That is an absent reading rather than a document without a class.

Status, and the dates it is held with

The status this record holds for this document, with its dates
FieldValue
Status unknown
Stated as of
In effect from
Last changed
Status read from
Status withdrawn
Decay class live

These are the dates this record holds for the document’s own status. They state nothing about which products or activities the document reaches; that is a judgment, and this record does not make one.

Verification

The act behind the status above, where one is recorded
FieldValue
State awaiting
What the state states not yet checked
Checked by
Check date
Last verified

Terms

What this record does with the text of this document
FieldValue
Licence class open
Text retained here yes
A quotation appears in this record yes
Snapshot retained here yes

Readings with retained text

Each distinct digest of the normalised text this record retained, addressed at the reading that first carried it
Reading Days seen Digest Class Answered at Bytes
 #1 4 — last 8b8ac787c6877a19… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 6 — last fa65ecef3a810b87… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 5 — last 8ee8e1aad0a5196c… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 2 — last f3605b69e136dcbd… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 6 — last baa155d883e3c444… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 1 ac6e97a3c75da60b… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 2 — last bb66b9cbb2c4048e… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,127
 #1 2 — last 0e1bbcb2d14d663f… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,195
 #1 6 — last 0eb9eade18684365… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 24,195
 #1 11 — last 94a77d5625e80437… document https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 23,183

Digests on this row: 10. With retained text: 10. Without: 0. Series state: comparable.

A digest is over the NORMALISED text of a reading, not over the bytes served: scripts, comments, navigation and page chrome are removed and tags are stripped before hashing. Hashing a source as served will not reproduce these digests. The full digest for every reading is in the packet; the column above is shortened for width.

Changes

One entry per consecutive pair of retained readings, in the order this record first saw each digest. Every entry carries a measured difference or the first condition that refused one. A refused entry was never tested against the conditions after it.

9 transition(s) between the 10 reading(s) above: 8 carry a measured difference, 1 are withheld above the word ceiling, 0 are refused by a rule, 0 differ in the digest and not in the words, and 0 could not be measured.

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest 8b8ac787c6877a1973785db6e13b8e6643271ebb4ee9403d7e9db717711c7124
Later digest fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
Later digest 8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest 8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
Later digest f3605b69e136dcbd96942e1b86545d684c1142b0bfee668ba2114db3fb5df41c
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest f3605b69e136dcbd96942e1b86545d684c1142b0bfee668ba2114db3fb5df41c
Later digest baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
Later digest ac6e97a3c75da60bbe14670cc9b3b4cc27356d812734f74467368d56a02ff579
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest ac6e97a3c75da60bbe14670cc9b3b4cc27356d812734f74467368d56a02ff579
Later digest bb66b9cbb2c4048ee8e7201c3dbc9998689b1b2cc89588d337d623462dec1d7d
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest bb66b9cbb2c4048ee8e7201c3dbc9998689b1b2cc89588d337d623462dec1d7d
Later digest 0e1bbcb2d14d663f658ef6b96d6d9e96dcca0b1578d109b833eef81beea80f9b
Verdict difference
Condition
Words differing 8
Removed 1
Added 7
The comparison entry the words that differ are published there

 #1  #1

The two readings, and the verdict on the pair
FieldValue
Earlier digest 0e1bbcb2d14d663f658ef6b96d6d9e96dcca0b1578d109b833eef81beea80f9b
Later digest 0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
Verdict difference
Condition
Words differing 2
Removed 1
Added 1
The comparison entry the words that differ are published there

 #1  #1

A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference.

The two readings, and the verdict on the pair
FieldValue
Earlier digest 0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
Later digest 94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
Verdict withheld
Condition over-ceiling (refused)
Words differing 84 (a lower bound)
Removed
Added
The comparison entry this pair on the comparison page, which publishes no words for it

A difference here is a difference between two readings this record retained. It is not a statement about what the document requires, about what changed in substance, or about whether anything follows from it.

Integrity

The root this packet was generated against
FieldValue
Root fd0980cf7ca42518ff7457b92b075df16163772d48d6f75e546b4869fe7bedab
Leaves the root covers 5,393
Algorithm SHA-256 over sorted `id|date|content_hash` lines, pairwise; an odd final node is promoted, never doubled.
Fixed on
Root published at /integrity/root.txt
Leaves published at /integrity/leaves.txt
The commands the verification page
Leaf lines for this row 45

The root is over every leaf line the record holds, not over the lines below. Reducing it needs the published file, which is served whole at the address named here together with the command that reduces it. These lines are this row's own slice of that file, copied verbatim.

us-21-cfr-part-820|2026-08-04|8b8ac787c6877a1973785db6e13b8e6643271ebb4ee9403d7e9db717711c7124
us-21-cfr-part-820|2026-08-05|8b8ac787c6877a1973785db6e13b8e6643271ebb4ee9403d7e9db717711c7124
us-21-cfr-part-820|2026-08-06|8b8ac787c6877a1973785db6e13b8e6643271ebb4ee9403d7e9db717711c7124
us-21-cfr-part-820|2026-08-07|8b8ac787c6877a1973785db6e13b8e6643271ebb4ee9403d7e9db717711c7124
us-21-cfr-part-820|2026-08-08|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-09|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-10|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-11|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-12|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-13|fa65ecef3a810b87382788c6b70bdfad819f167bc9bcf758ca15281140e88d63
us-21-cfr-part-820|2026-08-14|8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
us-21-cfr-part-820|2026-08-15|8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
us-21-cfr-part-820|2026-08-16|8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
us-21-cfr-part-820|2026-08-17|8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
us-21-cfr-part-820|2026-08-18|8ee8e1aad0a5196cfd8be9c3ea24d141240dbba3839be4290a3ab39607ca43a7
us-21-cfr-part-820|2026-08-19|f3605b69e136dcbd96942e1b86545d684c1142b0bfee668ba2114db3fb5df41c
us-21-cfr-part-820|2026-08-20|f3605b69e136dcbd96942e1b86545d684c1142b0bfee668ba2114db3fb5df41c
us-21-cfr-part-820|2026-08-21|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-22|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-23|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-25|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-26|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-27|baa155d883e3c444c5b7f46502cad12d29aa4a65ee0d9633c292e5f54ef6eb52
us-21-cfr-part-820|2026-08-28|ac6e97a3c75da60bbe14670cc9b3b4cc27356d812734f74467368d56a02ff579
us-21-cfr-part-820|2026-08-29|bb66b9cbb2c4048ee8e7201c3dbc9998689b1b2cc89588d337d623462dec1d7d
us-21-cfr-part-820|2026-08-30|bb66b9cbb2c4048ee8e7201c3dbc9998689b1b2cc89588d337d623462dec1d7d
us-21-cfr-part-820|2026-08-31|0e1bbcb2d14d663f658ef6b96d6d9e96dcca0b1578d109b833eef81beea80f9b
us-21-cfr-part-820|2026-09-01|0e1bbcb2d14d663f658ef6b96d6d9e96dcca0b1578d109b833eef81beea80f9b
us-21-cfr-part-820|2026-09-02|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-03|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-04|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-05|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-06|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-07|0eb9eade18684365c4e5887827e80f4e5d33640735d8c3f6aaf75bc73beb506d
us-21-cfr-part-820|2026-09-08|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-09|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-10|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-11|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-12|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-13|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-14|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-15|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-16|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-17|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1
us-21-cfr-part-820|2026-09-18|94a77d5625e80437cff61773776997c68ef0e942838a5c000c812e9dfc315ce1

What this packet does not carry

the words that differ
A count of a difference is in this packet; the words are not. They are a publisher's text, and this record checks borrowed text only on the surfaces it enumerates — a packet carrying spans under a key those checks do not read would be borrowed text nothing verifies. Each change names the comparison entry for the same pair, and says which of the two is at that address: the words, where a difference was measured and is inside the word ceiling; otherwise the same condition this entry names, with no text of the document.
this records own prose
The row's summary and its account of an unresolved address are this archive's own voice. They are leads and not evidence, however accurate, because a faithful paraphrase is indistinguishable from evidence while remaining ours. They are published on the row's page and are not here.
any field that would characterise a change
No score, no rank, no ordering by judgment, no reading of what a change means and no word for how much of it counts. A packet is evidence taken elsewhere, and a field characterising it would be an opinion with digests attached.
a recomputed root
The integrity block states the root this record published and the leaf lines for this row. It computes no root of its own: two numbers this record produced, compared with each other, check nothing.

The conditions, in the order they are evaluated

A change names the FIRST condition that fired and was never tested against the ones after it, so a condition naming no change here is not a condition this row passed. Not reached is not none: Three of the conditions belong to the form of the comparison that resolves two dates. Every comparison in this packet is formed from readings addressed by the key the store gives them, so those three are never evaluated here: their absence from the entries above records that they were not tested, rather than that they were tested and did not fire.

Each condition, how many of this row’s 9 transition(s) it refused, and what it states
Condition Changes What it states
licence-restricted none No text from this document appears on this site, so no difference between two readings of it is shown either. The digests, the dates and the addresses are the record for this row.
licence-unread none No reading of the terms this source states is recorded for the row. That is an absent reading rather than an absent term, and the row is handled here exactly as a restricted one until a reading is recorded.
date-not-observed not reached No observation of this row on that day holds retained text.
date-not-unique not reached That day holds more than one distinct retained digest for this row, so a date alone does not name one observation. The addressed form — the day and the sequence within it — does.
one-point not reached Both dates resolve to the same observation.
referent-unclassified none The class of one of these observations could not be read, so neither was shown to be an observation of the document itself.
referent-class none One of these observations is not of the document. A listing page that names the document and the document are different subjects, and a difference between them is not a difference in the document.
referent-normalisation none These two digests were taken over different kinds of text — one over markup, one over prose extracted from a file — so the words they yield differ for a reason that is not the publisher’s.
referent-address none These two observations answered at different addresses. A difference between them is at least in part a difference between two pages.
text-not-retained none No normalised text is held here for one of these observations, so there is nothing on this side to compare.
snapshot-unreadable none Normalised text is recorded for one of these observations and could not be read from this record.
span-unverified none A span this comparison would have shown could not be found, word for word and in that order, in the retained text it was drawn from. The comparison is withheld rather than shown: a phrase assembled out of words a publisher did not write next to each other is a fabricated measurement of what the publisher wrote.
over-ceiling 1 A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference.

Word ceiling: 14. Where a faithful difference is longer than that, the verdict is withheld and no words are published for it: a shortened span is a fabricated measurement of what a publisher wrote, so it is withheld whole rather than cut to fit. How this record is built.

Last updated: