Tests never touch production
A test that drives the real application is a production client until proven otherwise. Outbound writes are blocked at the network boundary, never with a flag inside application code.
Regulated Industries
Built for the day somebody asks you to prove it.
Healthcare, pharmacy and life sciences carry requirements that change how software has to be built. Not a harder version of ordinary software: a different discipline, applied from the first table.
- 01Append-only records
- 02Separation of duties
- 03Row isolation
- 04Evidence on demand
Why it is different
In most software, a bad record is an inconvenience.
Here it is a recall, a failed inspection, a payment that should not have gone out, or a patient who receives the wrong thing.
What we build in
The controls, not the checkbox.
These are properties of the system rather than features on a page. Added afterwards they are theatre; designed in, they are what lets a company answer a question in an afternoon instead of a fortnight.
- 01
Append-only records
Every action recorded and attributable, nothing silently changed. A record that can be quietly edited is not evidence, and reconstructing history from application logs after the fact is not either.
- 02
Separation of duties
Role-based access with approvals that cannot be self-signed. Two-person review where a single mistake would otherwise reach a patient, a shipment or a payment.
- 03
Tenant isolation at the row
Where multiple organizations share a system, isolation is enforced in the database, not by hiding options in the interface. A UI that hides a record is not access control.
- 04
Evidence on demand
When an inspector, auditor or acquirer asks what happened and when, the answer is a query. Not a week of reconstruction the month before a visit.
How we operate around live systems
The riskiest moment is not the build. It is everything that touches production afterwards.
No real-world side effects
Nothing in a test or a demo places an order, transmits a prescription, charges a card, or sends a message to a patient or a partner.
Data minimisation by default
Systems capture what the workflow requires and no more. The cheapest way to protect information is not to hold it.
Your judgment stays yours
Our software supports records and review. Clinical, dispensing and release decisions remain with your team, and we build so that stays unambiguous.
A note on claims
We describe what we build, not certifications we do not hold.
We design 21 CFR Part 11-aligned workflows and controls that inspectors look for. That is a description of engineering practice, not a certification.
TALK TO SOMEONE WHO HAS DONE IT
Tell us what you have to prove,
and to whom.
The requirement usually shapes the architecture more than the feature list does. That conversation is worth having before the scope is written.
Discuss a project