GxPlex

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GAMP 5 2nd Ed

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

not yet verified

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 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 (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.

Observation history

No observations recorded yet.

Sources