GxPlex

FDA CSA

Computer Software Assurance for Production and Quality System Software

not yet verified

Last verified: not yet verified Last observed: no observation recorded Tier: 1 · Sector: pharma

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Authority
US Food and Drug Administration
Jurisdiction
US
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
weekly
Crawlable
no
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Topics
software assurance · validation

Current status#

Status not yet verified against the primary source. Recorded as unknown rather than estimated.

Scope#

FDA guidance addressing assurance activities for computer software used in production and quality systems.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

NEEDS VERIFICATION. The regulatory status of this instrument has not yet been confirmed against its primary source. It is recorded as unknown rather than estimated. See /methodology for what verification means here.

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. Computer Software Assurance for Production and Quality System Software [instrument record]. Observed 28 July 2026. https://gxplex.com/instrument/fda-csa Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software

BibTeX

@misc{gxplexinstrumentfdacsa,
  author       = {{GxPlex}},
  title        = {{Computer Software Assurance for Production and Quality System Software}},
  year         = {2026},
  note         = {instrument record, observed 28 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/fda-csa}},
  urldate      = {2026-07-29},
  url          = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software}
}

APA

GxPlex. (2026). Computer Software Assurance for Production and Quality System Software [instrument record]. Retrieved 28 July 2026, from https://gxplex.com/instrument/fda-csa

Observation history

No observations recorded yet.

Archived versions

Change history

Sources