Insights
Notes on digital manufacturing, compliance and the NEO platform.
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.
Connecting the shop floor: which signals to start with, and why
You do not need to replace the installed base to get a connected plant. A sequencing argument for industrial IoT: which signals earn their connection first, and what each protocol is actually for.
Review by exception is an outcome, not a setting
Reviewing only what deviated is the standard promise of an EBR business case. It is achievable — but only once the system can be trusted to decide what counts as a deviation.
Serialization across ANVISA, FDA and the EU: what actually differs
Printing a unique code is the part everyone plans for. Aggregation, exception handling and per-market reporting are where serialization programmes actually spend their time.
Weighing and dispensing: the step you cannot undo
Most manufacturing errors can be caught downstream. A wrong material in a vessel usually cannot. That asymmetry is why dispensing earns enforcement before almost anything else.
Environmental monitoring: the excursion is the product, not the reading
Any system can log a temperature. What separates them is what happens on the day a cold room drifts — and whether the record can still answer for it two years later.
OEE that means something: definitions before dashboards
An OEE figure is a statement about definitions as much as about performance. If yours went up while output did not, the definitions moved — and the number stopped being useful.
From paper to paperless: a roadmap that survives contact with the plant
Digitisation programmes rarely fail on technology. They fail on sequence. A roadmap ordered by risk and payback, with what actually goes wrong at each step.
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.