FDA CSA

Computer Software Assurance for Production and Quality Management System Software

Document status what the publisher asserts

final

No status read is recorded for this entry — this record has not read a publisher surface for it, which is a fact about this record and not about the publisher. A status read is recorded for 7 of 132 tracked entries, 5 of which banked a passage.

Evidence state what this record holds

verified by a person — a person checked this entry against the primary source on a recorded day

Publisher: US Food and Drug Administration Last checked: 30 July 2026 Last read: 19 September 2026

How this status is recorded

Recorded: final — no as-of date is recorded
Established by: A person confirmed this entry on 30 July 2026.
Evidence: In Current status on this page.
Published at: This record names no separate surface for the status. The primary source it holds is the primary source (opens in new tab). This entry's record is published in machine form at /api/v1/instruments.json.

Evidence ladder#

What this record holds for this entry, rung by rung, each mark derived from a field, a count or a stored reading. Rungs in the order the record acquires them, from what an entry is to what has been checked about it. The order is fixed; a rung’s position says nothing about any entry.

held. identity an address that describes this document rather than a list it sits in This record holds an address that describes this document, and the names it is published under.
held. publisher the body that published it The publishing body is recorded as US Food and Drug Administration.
held. jurisdiction the jurisdiction the publishing body belongs to The jurisdiction is recorded as US.
read, and not there. type the class the document calls itself, quoted from its own title The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
held. current edition a statement of which edition or revision this record holds This record holds 1 archived version of this document, under the version label this record filed for it.
nothing held. publication date a date the publisher states for this document No reading of a publication date is recorded for this entry.
nothing held. lifecycle signal a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
nothing held. publisher notices official notices the publisher issued about this document No collection of publisher notices has succeeded: of 2 declared sources, 2 have never been attempted. The store holds nothing for any entry.
held. observation history a dated series of what the publisher’s address returned This record holds 126 dated records of this document, of 154 records in its series; the rest are classified as records of something other than the document this entry names.
held. text prose retained from the retrieved bytes, against which a quotation can be checked Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
held in part. diff a comparison of two retrievals of this document 126 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.
held. verification a person’s check of this entry against the primary source A person checked this entry against the primary source; the day is recorded above.

✓ held — this record holds it, and the sentence beside it names what from · ✗ read, and not there — a reading ran and did not find it — an absence this record measured · — nothing held — no reading of this rung is recorded — nobody has looked, which is not the same as looking and finding nothing · △ held in part — part of it is held, or it is held under a limit the sentence states

The first rung a reading ran on and did not find: type — The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.

What the evidence states

This record holds an address that describes this document, and the names it is published under.
The publishing body is recorded as US Food and Drug Administration.
The jurisdiction is recorded as US.
This record holds 1 archived version of this document, under the version label this record filed for it.
This record holds 126 dated records of this document, of 154 records in its series; the rest are classified as records of something other than the document this entry names.
Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
A person checked this entry against the primary source; the day is recorded above.

What it does not state

The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
No reading of a publication date is recorded for this entry.
No read of a publisher surface for a stage or status wording is recorded for this entry.
No collection of publisher notices has succeeded: of 2 declared sources, 2 have never been attempted. The store holds nothing for any entry.
126 retrievals of this document carry a digest, and the store records no retrieval differing from the one before it.

Coverage contract#

Each term states what this record does for this entry and what it does not, derived from the entry’s own fields and its own series. It is a record of coverage, not a finding about the document.

Observed cadence how often this record has reached this entry’s address: Every interval between consecutive days holding an observation is 1 day. The term this record declares for the entry is “weekly”.
Text: public, and retained whether the publisher’s text is public, and whether prose from it is kept here: The publisher’s text is freely reproducible. Prose is retained from the retrieved bytes, so a quotation can be checked against it.
Hash what is digested for this entry, and of what: 126 of 126 record(s) classified as being of the document this entry names carry a digest of the retrieved bytes; the entry’s whole series holds 154 record(s), and the rest are classified as records of something other than that document.
Status verification which check this record undertakes for the published status, and which it holds: This entry’s label asks for a person’s check. A person’s confirmation is recorded, dated 2026-07-30.
Lifecycle tracked which lifecycle facts this record follows for this entry: This record follows 1 archived version(s) for this entry. 36 of 132 tracked entries carry at least one such fact.
Known limits the limits this entry’s own record declares: None of the 8 limits this record can record is set on this entry. That is an absence of declared limits, and not a finding that the entry has none.

Why this entry is tracked#

The test an entry is admitted under is published in full, with its negative limb and its worked examples, at the inclusion rule. What this record holds about THIS entry's admission is below, each line naming the store it was read from.

Inclusion-rule limb which of the four limbs was applied: — No field in this record names which limb an entry satisfies, so none is stated for this one. Membership was closed as a human judgment on 2026-08-11, and the four-limb test is applied by a person rather than by code. This entry’s own stated subject is not read as a limb: a title word standing in for a rule would be a classification this record authored.
Admission entry the dated act that added this entry: — No admission entry is recorded for this entry. 21 of 132 tracked entries carry one, so an absence here is ordinary rather than a gap peculiar to this entry.
Declared tier-1 list a recorded judgement that this belongs: This entry is a member of the declared tier-1 list, which names 37 identifiers, of which 35 resolve to one of the 132 tracked entries. The list records a decision that these belong; it states no limb.
Admissions boundary the jurisdictions this record adds from: This entry’s jurisdiction is US. It is inside the admissions boundary ruled on 2026-08-16, which names 4 jurisdictions — EU · US · UK · International — and which is one of the two admission tests this record enforces in code. The other is that a candidate carry the publisher’s own address: a mention is not a citation.

Filed core. For that label this archive undertakes to put an entry's status to a person. The label records what this archive undertakes for a class of entries. It states no finding about this one, and it is not a ranking.

Resolution: direct document

Authority: US Food and Drug Administration
Jurisdiction: US
Status: final
Effective date: —
Last changed: —
Last verified: 30 July 2026
Watch cadence: weekly
Crawlable: yes · renders server-side
Text licence: freely reproducible
Primary source: Primary source (opens in new tab) fda.gov
Topics: computer software · quality management · software

Current status#

Recorded as final against the primary source on 30 July 2026.

The supporting text is not reproduced here. This archive superseded the reading behind this entry on 30 July 2026: the passage that was read names the document this guidance supersedes, and this document's own title does not appear in it. The superseded passage is not reproduced here. It was retrieved 30 July 2026 by html and is at the location below, in the primary source.

Found at: /files/api/datatables/static/search-for-guidance.json

Cite this document

Each format carries the permalink and the date this document was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. Computer Software Assurance for Production and Quality Management System Software [document record]. Observed 19 September 2026. https://gxplex.com/r/fda-csa Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software

BibTeX

@misc{gxplexrfdacsa,
  author       = {{GxPlex}},
  title        = {{Computer Software Assurance for Production and Quality Management System Software}},
  year         = {2026},
  note         = {document record, observed 19 September 2026},
  howpublished = {\url{https://gxplex.com/r/fda-csa}},
  urldate      = {2026-09-19},
  url          = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software}
}

APA

GxPlex. (2026). Computer Software Assurance for Production and Quality Management System Software [document record]. Retrieved 19 September 2026, from https://gxplex.com/r/fda-csa

JSON

{
  "@context": "https://schema.org",
  "@type": "Dataset",
  "name": "Computer Software Assurance for Production and Quality Management System Software",
  "publisher": "GxPlex",
  "url": "https://gxplex.com/r/fda-csa",
  "temporalCoverage": "2026-09-19",
  "observation": {
    "url": "https://gxplex.com/observations/fda-csa#obs-2026-09-19-1",
    "observedDate": "2026-09-19",
    "sha256": "4843091843f0704b36f6b3f40aaf76fc1a06f5866feaa0621f4572c3e879e3dd",
    "verifiedAt": "https://gxplex.com/verify"
  },
  "isBasedOn": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software"
}

observation.url addresses the single observation this citation rests on.

Every observation of this document is addressed and separately citable at the observation series.

Observation history#

Observed on 154 occasion(s) since 2026-07-28. 126 produced a content hash. No change to the retrieved text has been detected since observation began.

××××××××××××××××××××××××××××······························································································································

All 154 marks, one per observation, oldest first. · unchanged · ! content changed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash.

Every one of the 54 days from 2026-07-28 to 2026-09-19 holds an observation.

28 of these 154 record(s) are held in this series and left out of every count of the document series , each where the landing URL is a listing or search path. None was hashed. They are dated 2026-07-28 to 2026-07-30 . Nothing was rewritten: each record stands in the store as it was written, with its address, its response and its digest, and the annotation sits beside it. The ruling is of 2026-09-12. The document series this entry holds is 126 record(s), and it is what the windows in Neighbourhood below count.

Each mark links to the single observation it stands for, at that observation’s own address. The whole series, with every address, is at /observations/fda-csa. Any two of its retained observations can be set side by side at /compare/fda-csa. The same evidence as a packet, with its refusals and its integrity reference, is at /packet/fda-csa.

Every observation in this series is published, untruncated, at /api/v1/observations.json.

First observed: 2026-07-28
Last observed: 2026-09-19 (HTTP 200)
Fetch method: direct
Current hash: 4843091843f0704b36f6b3f40aaf76fc1a06f5866feaa0621f4572c3e879e3dd

How this series is recorded

Recorded: observations: 154 · carrying a digest: 126 · changes detected: 0 · first observed: 2026-07-28
Method: resolution: direct document · watch cadence: weekly · last fetch method: direct
Evidence: The most recent record is addressed at 2026-09-19·1.
Published at: /observations/fda-csa — every record of this row, with its address. /api/v1/series.jsonl — the same records for every row, one line each. Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them.

Source health#

Counts and dates over a stated window. No figure here is a mark out of a hundred, no cell is ordered against another, and none of it is a statement about the publisher: a day this record did not reach is a fact about this record’s reach.

Fetch outcomes how the requests in the window answered: 126 of 154 fetch records in the 90 calendar days ending 2026-09-19 carry no error. The 28 that carry one are recorded under blocked ×28.
Last fetched the most recent record in the whole series: 2026-09-19 — the latest day this record holds (2026-09-19). The method recorded is direct. What that record returned is in Observation history above.
Address stability where the requests actually landed: 97 record(s) in the window recorded the address that answered, across 1 distinct address(es). 57 further record(s) carry no answered address and say nothing either way. The most recent answered address is the one this entry declares.
Access posture what the publisher declares, and what the requests met: Declared: no AI-specific disallow · crawlable yes · renders server-side. Met: 28 of 154 record(s) in the window were recorded as refused. A refusal is what one request of this record met on one day; it is not a policy the publisher stated.
Expected and observed cadence the declared term, the days held, and the days holding none: The term this record declares for this entry is weekly. Over its own window, 2026-07-28 to 2026-09-19, 54 of 54 calendar days hold at least one observation. None holds none. Every interval between consecutive days holding one is 1, counted in days. Both figures are stated and the difference between them is not adjudicated here.

Neighbourhood#

What sits around this entry, counted. Every figure below is drawn from a value already rendered elsewhere on this page; where a count has a list, the count is here and the list stays in the section holding its evidence.

The direct document, and the activity around it what this record’s observations of the document recorded inside a stated window, beside the official signals dated inside the same one

Each row is a window of calendar days ending 2026-09-19, the day the source-health block above counts its own window to. Every column between the window and the official signals is drawn from the 126 observation(s) of the document this entry holds in total. An observation is counted here only where the class projection places it on the document this entry names.
Window	Observations of the document	Of those, carrying a digest	Direct document	Official signals dated inside it
30 calendar days	45	45	no change in window	0 of 0
90 calendar days	126	126	no change in window	0 of 0
365 calendar days	126	126	no change in window	0 of 0

A window is marked changed where at least one observation of the document inside it recorded a change against the previous one; unchanged where the window holds at least one such observation, at least one of them carries a digest of the retrieved bytes, and none recorded a change; undigested where the window holds observations and none of them carries a digest, so no observation in it could be compared with another; and unmeasured where the window holds no observation at all. The word is shorthand for the three counts printed beside it and adds nothing to them. It is a statement about the window and never about the document outside it, which is why a window reaching back before the first observation says so underneath. A mark is derived from the observations a window holds and never from the days it spans; which days inside this entry’s own window hold none is stated by the coverage sentence in Observation history above.

The first observation of the document this entry names is 2026-07-30. These windows reach back before it — 90 calendar days · 365 calendar days — so part of the span each names was never watched, and a window with no change inside it says nothing about the days before that first observation.

no change in window — this window holds observations of the document and none of them recorded a change — which is a statement about the window, not about the document outside it

No word is attached to the signal count beside it, and none will be. Any word for the size of a count needs either a threshold this record would have authored or a comparison against other entries that would rank the sources against one another; the count and its window are the whole claim. The document column beside it carries a word only because the rule reaching it is printed underneath and can be checked against the counts it stands for.

The last column holds no member on this entry. The zero it holds is named under “Around it” below.

Around it official signals naming this entry, by the class their publisher stated

— The signal store holds no record for any entry, so nothing here is an absence measured on this one. The store’s own state is no source attempted, and what that state means for every count drawn from the store is stated at the signals index.

Related sources other entries reachable from this one by a relation a publisher states

— This record publishes no relation from or to this entry. A relation is published only where a publisher states it, so this is the absence of a statement this record has read and not a claim that none exists.

Related standards which of those entries call themselves a standard, in their own publisher’s word

— No published relation from this entry reaches an entry this record tracks, so there is nothing to place on this axis. That is a statement about what this record can read, not about what exists.

Topics the controlled identifiers this entry carries, and the voice each one is in

3 identifier(s), minted by the convention published at /conventions. The values themselves are not listed again here; what this adds is the identifier and the voice it is in. 3 come(s) from a term this document’s own publisher states about it, quoted with its citation lower on this page: topic.computer-software · topic.quality-management · topic.software.

Before, now and next where the record’s day sits among the publisher-dated facts this entry holds

— This entry holds no publisher-dated lifecycle fact, so no position can be derived. What is absent is a dated statement this record has read.

Next holds the publisher-dated facts this record already carries that fall after the day this record calls today — a stated effective date, a consultation close. Nothing is projected and no step is inferred from a lifecycle: where a publisher has stated no further date, the cell says so, and what is absent is a statement rather than a future.

SHA-256: 4843091843f0704b36f6b3f40aaf76fc1a06f5866feaa0621f4572c3e879e3dd This digest is a leaf of the integrity root, and the command that recomputes it is published at /how.

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

subject computer software
Computer Software Assurance for Production and Quality Management System Software source (opens in new tab) fda.gov
subject quality management
Computer Software Assurance for Production and Quality Management System Software source (opens in new tab) fda.gov
subject software
Computer Software Assurance for Production and Quality Management System Software source (opens in new tab) fda.gov

This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under title states no class.

Archived versions

URL dead as of 2026-07-29 — retrieved 2026-07-29 · original link dead

Change history

2026-09-12 — archive metadata change correction: this entry's document-series count leaves 28 records out, and no page said so or on whose word. Nothing is rewritten; the 28 are now stated as held and excluded.
2026-09-02 — archive metadata change (a 27-word quotation, over the 14-word cap → no quotation published; the reason is stated on the row) correction: the quotation here exceeded the 14-word cap and no compliant span exists in the banked evidence, so none is published. Withheld rather than shortened.
2026-08-29 — archive metadata change (fda.gov drops automated clients, so the guidance page cannot be read directly. The Federal Register records its issuance on 24 September 2025; that date is evidence and is waiting on a person to confirm the status it implies. → no account. The field is withheld: the row resolves to a document, hashes it, and its status carries a recorded human confirmation, so there is nothing unresolved for it to account for.) correction: this row's account said fda.gov drops automated clients and that its status awaited a person. Both were false when the sentence was written. The account is withheld, not rewritten.
2026-07-30 — status change (unknown → final) correction: the status moved unknown to final at commit 0d8fe64c on 2026-07-30 and no changelog entry was written at the time. Recorded 2026-09-01 from git history.
2026-07-29 — date change (resolving → error page) correction: primary source URL no longer resolves

Sources#

Primary source (opens in new tab) fda.gov
Archived copy (opens in new tab) web.archive.org · retrieved 29 Jul 2026

Listed primary first, then the further addresses this record holds for this entry, then the route it was found by, then dated third-party copies. Repeated URLs appear once, at their first position.

Last updated: 30 July 2026