We automate the workflows that define your compliance posture — deviation management, batch record review, change control, CAPA closure, and supplier qualification — with every automation validated under GxP from day one. No retrofitting. No regulatory exposure. No surprises at inspection.
If it touches a GxP record, it can be automated — and it must be validated. We do both, simultaneously, from a single engagement. No separate automation team. No separate validation consultant. One practice, end-to-end.
End-to-end automation of deviation initiation, investigation routing, root cause documentation, CAPA assignment, effectiveness check scheduling, and management review — with AI-powered triage and classification built in.
Paperless batch record design, execution workflow automation, in-process check orchestration, and exception-based review — replacing manual paper processes with validated electronic records that satisfy 21 CFR Part 11 from go-live.
Intelligent change request classification, impact assessment routing, validation requirement determination, regulatory submission flagging, and change implementation verification — with full audit trail from initiation to closure.
Sample management automation, instrument data integration, out-of-specification (OOS) investigation workflow, analytical method scheduling, stability program management, and certificate of analysis generation — all GMP-compliant.
Role-based training curriculum automation, qualification status gating for manufacturing access, retraining triggers on SOP changes, training effectiveness assessment workflows, and automated compliance reporting for management review.
Automated supplier qualification workflows, annual product quality review (APQR) data aggregation from MES and LIMS, supplier audit scheduling, certificate management, and supply chain risk scoring aligned with ICH Q10 and FDA expectations.
We work across every layer of your manufacturing technology stack — from the plant floor to the enterprise — integrating and validating each layer to create a seamless, compliant data flow.
Isolated systems create data integrity risk. We design and validate the integrations between your systems — so data flows without human transcription, audit trails are unbroken, and your compliance posture strengthens as your automation matures.
We do not automate first and validate later. Every automation is designed with its validation evidence in mind — which is why our engagements deliver compliant systems in a fraction of the time traditional approaches require.
We do not separate the automation engineer from the validation consultant. Our practitioners design automation and write validation protocols — which means the system is built to be validated, not retrofitted for it.
Many automation projects launch and then spend months closing out validation evidence. We deliver both together — so your go-live date is the same as your compliance date. No open items that create inspection exposure.
Every integration, every data transfer, every automated workflow is designed with ALCOA+ principles at the architecture level — not as an afterthought. Attributable, legible, contemporaneous records from day one.
Our agentic AI platform reduces the time to produce validation evidence by 50–70% — protocol authoring, test script generation, summary reports. The same rigorous output. Half the clock time. Full audit trail.
Tell us what system you're automating, what regulatory framework governs it, and what your timeline looks like. We'll show you exactly how we deliver automation and validation in a single, accelerated engagement.