REGQUALITYREVIEW

Evidence for systems that carry regulated work.

Coverage desk

CAPA Governance

Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.

AmpleLogic CAPA consolidation needs separate lineage

AmpleLogic says its AI Effectiveness Intelligence compares each new CAPA with open effectiveness-check CAPAs of a similar nature, flags overlaps, and recommends consolidation. A quality unit should preserve every originating event, investigation, action, owner, due date, risk scope, and effectiveness question before approving a shared plan or cross-reference.

LORENZ RIM permissions need product-and-market scope

LORENZ says its RIM platform centralizes administration while allowing organizations to customize who can view, edit, or manage regulatory information. A permission is defensible only when it is bound to the regulated object, product, market, action, lifecycle state, purpose, and effective period it actually authorizes.

Scilife controlled copies need issuance and return lineage

Scilife describes controlled printing and reconciliation alongside its document-management workflows. A printed copy still needs a durable identity, point-of-use owner, issuance history, reconciliation state, and retirement evidence before teams can know which instruction was available for regulated work.

EMA opens PMS product data through a public API beta

The June release expands access to structured medicinal-product data while marketing authorisation holders face staged manufacturer and pack-data enrichment deadlines.