Hub
CAPA & deviation systems
Root cause discipline, effectiveness checks, backlog recovery, recurrence trending.
In preparationInsights
Inspection intelligence, not content marketing
Written for people who already know what a CAPA is. Each briefing takes one theme that inspectors keep returning to and works out what it means for a site with a lean QA team and no spare capacity.
Editorial policy
We publish when we have something specific to say. No news roundups, no reposted guidance summaries, no articles titled “What is GMP?”.
Topic hubsIn preparation
The four themes we write about
Hub
Data integrity
ALCOA+ in practice, audit trail review that is actually performed, hybrid paper systems.
In preparation
Hub
Annex 1 & sterile
Contamination control strategy, EM programme design, aseptic process assessment.
In preparation
Hub
Inspection readiness
Retrieval speed, back-room function, SME behaviour, closing previous commitments.
In preparationPublication planTitles and quarters are the intended plan, not commitments.
What is scheduled
- Briefing · Q1
Why "human error" is the most expensive root cause you can write
What it costs a site to close investigations on retraining, and what inspectors read into a deviation log where it appears repeatedly.
- Briefing · Q1
The CAPA effectiveness check nobody defines in advance
Setting a measurable criterion before implementation, and what to do with a backlog of CAPAs closed without one.
- Guide · Q2
Fifteen minutes: document retrieval as an inspection risk
Most sites lose credibility in the first hour on retrieval speed, not on compliance. A practical drill and a scoring sheet.
- Guide · Q2
Annex 1 contamination control strategy for small sterile sites
Writing a CCS that is a working document rather than a compilation of existing SOP references.
- Research · Q3
Netherlands GMP Readiness Index 2027
Our first annual benchmark, built from anonymised, aggregated readiness assessments taken on this site: how Dutch life-science sites score by domain, by size, and by sector.
Want one of these sooner, or a theme that is not listed? Tell us which — that is how the order gets set.
On the 2027 Index. The benchmark will be built only from aggregated, anonymised assessment results, reported at domain level. No individual site, score or company will be identifiable, and participation will be opt-in.
Next step
Ask for a specific briefing
Tell us which theme would be useful this quarter, or contribute a readiness score to the benchmark.