GxPlex

GAMP 5 2nd Ed

ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)

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
ISPE
Jurisdiction
International
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
quarterly
Crawlable
yes · renders server-side
Text licence
restricted — cited and linked, never excerpted (paywalled standard)
Primary source
Primary source (opens in new tab) ispe.org
Topics
computerised systems · software categories

Current status#

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

Scope#

Industry guide published by ISPE addressing computerised systems in regulated environments.

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. ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [instrument record]. Observed 28 July 2026. https://gxplex.com/instrument/ispe-gamp5-2e Primary source: https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition

BibTeX

@misc{gxplexinstrumentispegamp52e,
  author       = {{GxPlex}},
  title        = {{ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)}},
  year         = {2026},
  note         = {instrument record, observed 28 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/ispe-gamp5-2e}},
  urldate      = {2026-07-29},
  url          = {https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition}
}

APA

GxPlex. (2026). ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [instrument record]. Retrieved 28 July 2026, from https://gxplex.com/instrument/ispe-gamp5-2e

Observation history

No observations recorded yet.

Sources