Insights
Notes on digital manufacturing, compliance and the NEO platform.
Holding time: the study sets the limit; the routine is where it fails
RDC 658/2022 (art. 274) requires stability of intermediates and bulk. The real cost shows up when the limit exists in the report and disappears on the shop floor.
The electronic batch record: enforcement, not just the removal of paper
An EBR that only replaces paper buys very little. The value is a process enforced while it runs — and that has design costs worth understanding before you specify one.
Computerised system validation without the paperwork spiral
GAMP 5 asks for effort proportional to risk, yet most validation packages scale with page count instead. What a risk-based approach changes in practice, and what it does not excuse.
ALCOA+ in practice: what data integrity actually demands of your systems
ALCOA+ is quoted in every audit and understood in few. A principle-by-principle walk through what each one demands, the failure modes inspectors actually find, and where system design decides the outcome.