GxPlex

FDA software validation

General Principles of Software Validation

final as of 9 June 1997

Last verified: Last observed: SHA-256: c49d3a7195156124103da7495e93222a836fcff8c8b92310eca57171bb2677ea

Resolution: direct document

Authority
US Food and Drug Administration
Jurisdiction
US
Status
final
Effective date
—
Last changed
—
Last verified
:
Watch cadence
monthly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Topics
software validation · computerised systems · medical devices

Current status#

Recorded as final against the primary source on 31 July 2026.

No evidence record is stored for the current status.

Observation history#

First observed 31 July 2026. Last observed 3 August 2026. 14 observation(s) recorded.

14 of those returned a document to a standard HTTP client and produced a content hash.

No change to the retrieved text has been detected since observation began.

Sources#

Cite this instrument

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

Plain text

GxPlex. General Principles of Software Validation [instrument record]. Observed 31 July 2026. https://gxplex.com/instrument/fda-software-validation Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

BibTeX

@misc{gxplexinstrumentfdasoftwarevalidat,
  author       = {{GxPlex}},
  title        = {{General Principles of Software Validation}},
  year         = {2026},
  note         = {instrument record, observed 31 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-software-validation}},
  urldate      = {2026-07-31},
  url          = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation}
}

APA

GxPlex. (2026). General Principles of Software Validation [instrument record]. Retrieved 31 July 2026, from https://gxplex.com/instrument/fda-software-validation

Observation history

Observed on 14 occasion(s) since 2026-07-31. 14 produced a content hash.

··············

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

First observed
2026-07-31
Last observed
2026-08-03 (HTTP 200)
Fetch method
direct
Current hash
c49d3a7195156124103da7495e93222a836fcff8c8b92310eca57171bb2677ea

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.

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

Other instruments addressing the same subjects

A citation index only: both documents address the subject. This states no relationship between their requirements.

Sources

Last updated: