Take the paper out of manufacturing — connected, validated, audit-ready operations that lift throughput without ever compromising compliance.
Paper batch records, disconnected equipment and manual data entry quietly cost pharma manufacturers time, money and peace of mind — and they turn every audit into an ordeal.
Our digitalization program replaces paper with electronic batch records, connects your equipment and systems, and gives your teams real-time visibility — all engineered to meet 21 CFR Part 11, GAMP 5 and ALCOA+ data integrity from the ground up.
The outcome: faster batch release, fewer deviations, and records that make audits almost boring. Digitalization that strengthens compliance rather than threatening it.
See how we engageElectronic records and automated review cut release times dramatically.
Guided workflows and built-in checks reduce human error at the source.
Complete, tamper-evident records mean audits become a few clicks.
See throughput, downtime and quality across the floor as it happens.
ALCOA+ and 21 CFR Part 11 built in, not bolted on.
Less rework, less paper, less time chasing signatures.
We deliver the full stack of digitalization — engineered for validation and integrated end to end.
No black boxes — you’ll always know what’s happening and what’s next.
Book a discovery callWe map your process and data flows, then pilot on a single line to prove value and approach.
We design the solution and validation strategy together, so compliance is engineered in.
We digitalize line by line, validating each step, so production keeps running throughout.
With the plant connected, we tune performance and support ongoing compliance.
GMP, GAMP 5 and 21 CFR Part 11 are design inputs, not afterthoughts.
We connect MES, ERP, LIMS, SCADA and equipment into one reliable flow.
CSV-conscious throughout, keeping validation efficient and defensible.
Flexible models so you get exactly the level of support you need — no more, no less.
A focused review of your process, systems and data integrity, with a prioritized roadmap.
Digitalize one line end to end to prove value and approach before scaling.
A phased, validated rollout across your plant with ongoing support.
The move to a paperless floor was the smoothest technology project we’ve run. Clear plan, senior people, and results we could take straight to an audit.
Marcus Feld
Head of Operations, Meridian Pharma
Let’s start with a focused pilot on one line and prove the value before you scale.