Enterprise & Operations
OT & Regulated Environments
A qualified system that works is worth more than a modern one that needs revalidating. In plants, labs and regulated estates the rule is to change as little as possible, and to prove what you did. We engineer and protect these environments on those terms: nothing installed on a validated host unless it has been qualified, change control respected, and documentation written for the people who sign it off.
What We Build
Engineering that leaves qualified systems alone
Six services, standalone or combined. Every engagement starts with a register of what is validated and what cannot be touched.
OT & IT Integration
Plant data delivered to the business through gateways and one-way paths that leave control networks untouched.
Validated System Support
Changes to GxP systems delivered with the documentation your quality team needs to sign them off.
Data Protection for Plants
Backup and recovery designed for air-gapped operation, including nSecureBackup™ Vault, with nothing installed on a qualified host until it has been assessed and approved.
Legacy System Containment
Old operating systems and controllers kept running safely when replacing them is not yet an option.
Edge & Shop-Floor Applications
Applications at the line, built to keep working when the network link to the data centre does not.
Compliance Documentation
Requirements, risk assessments and test evidence written to GAMP 5 practice, with 21 CFR Part 11 and EU Annex 11 in view.
HOW IT RUNS
Four phases, from survey to audit trail
Each phase ends with something you can hold: a system register, an approved design, executed test evidence, an audit trail.
Site & System Survey
We record every system in scope, its validation status, the network zones it sits in, and the constraints that come with it.
DELIVERABLES
- Register of systems and validation status
- Network zones and data flows
- Change-control procedure review
- Constraints list: agents, downtime, vendors
- Risk assessment
- Proposed scope
Read This First
Three cases to leave a regulated system alone
Sometimes the right change is no change:
It Works and Is Qualified
If the system meets its purpose and can still be supported, wrapping it is usually safer than replacing it.
No Quality Sign-Off Available
Without someone in quality to review and approve, changes to validated systems should not start.
Production Can't Spare a Window
Some work needs downtime. If the plant cannot give a window, plan the work for the next shutdown rather than squeezing it in.
How We Work
How we work in regulated estates
nSecureBackup™ is our own backup and recovery platform, built for environments like these.
01
Agentless by Default
Nothing is installed on a qualified host unless it has been assessed and approved.
02
Air-Gapped Where Required
nSecureBackup Vault runs air-gapped on your own infrastructure.
03
Documentation for Signers
Every change comes with the evidence your quality team needs to approve it.
04
Your Change Control
We work inside your procedures, not around them.
FAQs
Regulated environments, answered
Not by default. Where an agent is the only option, it goes through your change control and qualification like any other change.
We work in GxP-regulated environments, writing to GAMP 5 practice with 21 CFR Part 11 and EU Annex 11 in view. Your quality procedures take precedence.
Yes. nSecureBackup Vault runs air-gapped on your own infrastructure, and every restore point carries a signed manifest, so a recovery is verified before it is trusted.
No. We work alongside the vendors who support your control systems, and coordinate changes with them.
Change as little
as you need to.
Tell us which systems are validated, what the constraints are, and what needs to change. The first step is a site and system survey, and a plain account of what can be done without touching qualified systems.
Have a project in mind?
Start with a survey of what can stay untouched.