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Standards we work to: GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity, PIC/S Guidance, ISO 9001:2015, EudraLex Vol 4, Validation Master Plan, Risk-Based · FMEA, CSA · Software Assurance, Audit-Ready Documentation, SDLC

APQR

APQR documents,drafted from batch records.

Generate Annual Product Quality Review documents from Master Batch Records with generative AI assistance and human review.

What it does

Fit the software to the way you work

The APQR application helps teams organise relevant Master Batch Record information and prepare a structured first draft for review. Generative AI assists the document-generation step while the quality team remains responsible for verification and approval.

Core capabilities

Turn controlled processes into visible progress

Master Batch Record input

Bring relevant batch information together as the controlled source for APQR preparation.

AI-assisted drafting

Use generative AI to prepare a structured document draft from the available records.

Review-ready output

Present the generated content for quality review, correction and approval before finalisation.

Next step

See how APQR fits your workflow.

Bring your current process. We will map the fit, identify the right controls and show you the shortest route to a working, validation-ready system.