3 packages matching “gamp5”

@lekman/n8n-local-deploy

v0.5.5 · 8 months ago

100
0-100 score computed by this site from verifiable signals only: known OSV.dev advisories affecting this exact version, how recently it was published, and the repository's OpenSSF Scorecard.

One-command installer for n8n workflow automation with GAMP5 IQ/OQ validation

8Downloads across all versions in the last 7 days, from the official npm downloads API.MITLicense declared in the package manifest.

No known vulnerabilities

Known vulnerabilities affecting v0.5.5 (the latest release), from the OSV.dev database.

@makerchecker/obligations

v1.2.0 · 3 months ago

100
0-100 score computed by this site from verifiable signals only: known OSV.dev advisories affecting this exact version, how recently it was published, and the repository's OpenSSF Scorecard.

Deterministic, offline mapping of a signed MakerChecker audit bundle to named regulatory obligations (21 CFR Part 11, EU Annex 11, GAMP 5, HIPAA 164.312). Emits MET / NOT_EVIDENCED / NOT_APPLICABLE per clause with citing seqs.

1Downloads across all versions in the last 7 days, from the official npm downloads API.Apache-2.0License declared in the package manifest.

No known vulnerabilities

Known vulnerabilities affecting v1.2.0 (the latest release), from the OSV.dev database.

@makerchecker/validation-kit

v1.2.0 · 3 months ago

100
0-100 score computed by this site from verifiable signals only: known OSV.dev advisories affecting this exact version, how recently it was published, and the repository's OpenSSF Scorecard.

Generate a Computer System Validation (IQ/OQ/PQ) report and Requirements Traceability Matrix deterministically from a signed MakerChecker audit bundle. The GxP validation package a regulated QA function drops into its binder.

2Downloads across all versions in the last 7 days, from the official npm downloads API.Apache-2.0License declared in the package manifest.

No known vulnerabilities

Known vulnerabilities affecting v1.2.0 (the latest release), from the OSV.dev database.