GMP eArchive Readiness Check

Check whether your electronic archiving meets the requirements for GMP-regulated environments: governance, retrievability, audit trails, Annex 11 validation and legacy risks.

Question 1 of 5

Are all GMP-relevant records clearly identified and assigned to a defined archive location?

Governance and classification, EU GMP Annex 11 §8.

Orientation only, not a substitute for a regulatory assessment.

Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

ArticleMay 6, 2026

CSV Does Not End at Qualification: Periodic Review and Change Control as Common Findings

Many computerised systems are cleanly qualified at go-live and then left to their own devices. That is exactly where the major findings arise: missing periodic reviews and a gap-ridden change control history under EU GMP Annex 11.

ArticleApr 2, 2026

Agile or Waterfall? Why Pharma Projects Must Align the Method With the Question

Whether waterfall or agile is the right approach is not decided in pharma projects by method preference, but by the regulatory character of the undertaking. Where validation-driven projects need structure, where digitalization benefits from iteration, and why the hybrid approach usually wins.

Need support with implementation?

The tool provides initial guidance. For your specific situation, we clarify the right approach in a first call.

Speak with an expert All consulting formats