Role 01
Agent as Developer
Designs, writes, and integrates the software against your requirements — producing specifications and traceable commits as it goes.
Agent-first SDLC · Regulated industries
Validated software,
shipped in weeks — not months.
A compliance-native, agent-first software development lifecycle for regulated teams. Autonomous agents build, validate, and operate the software — generating the audit trail as the work happens, not after.
Built for pharma, life sciences & financial services
Trusted by teams in regulated industries
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The problem
In regulated software, the code is the easy part.
Every line has to be validated, documented, and made audit-ready. That work — not the engineering — is what stretches delivery from weeks into quarters, and it is usually done by hand, after the fact, by the people least able to spare the time.
.01
Validation dominates the timeline
Computer-system validation, test evidence, and documentation routinely take longer than building the feature they cover.
.02
Compliance is bolted on last
Traceability and QC get reconstructed at the end, when context has been lost — the slowest and most error-prone moment to do it.
.03
Every audit restarts the work
Without a living, generated record, each inspection means re-assembling evidence that should have existed from day one.
How it works
Three roles, run by agents — across the whole build.
OneCliq's agent-first SDLC assigns autonomous agents to the three roles a regulated build needs. They work in concert, and the compliance record is a product of their work — not a separate project.
Role 02
Agent as QC / Validation
Independently tests, challenges, and validates every change — generating executed test evidence and the validation package alongside the build.
Role 03
Agent as Operations Enabler
Prepares deployment, monitoring, and the audit-ready handover so the software can go into regulated production and stay compliant.
The agent-first SDLC
Plan → Build → Validate → Ship
Compliance, traceability, and QC are generated at each step — as the work happens.
The result is a validation package that is complete the moment the software is — because it was assembled continuously, with full traceability from requirement to release.
Why OneCliq is different
Not AI that writes code faster. AI that ships compliant software.
General coding assistants make engineers quicker. They do not carry the regulatory context, produce defensible evidence, or stand behind a validated release. That difference is the entire job in a regulated environment.
.01
Compliance-native by construction
GxP and computer-system-validation expectations are encoded into how the agents work — so controls are met by default, not remembered at the end.
.02
Audit-grade traceability
Every requirement links to the code that implements it, the test that proves it, and the record that signs it off — one continuous, inspectable thread.
.03
Domain context, not generic autocomplete
The agents are grounded in the regulations, terminology, and quality expectations of your industry — context a general-purpose tool cannot replicate.
Industries
Built for the sectors where evidence is the deliverable.
Primary
Pharma & Life Sciences
Software built to withstand GxP scrutiny — with computer-system validation, audit trails, and traceability produced as part of the build.
- GxP & computer-system validation (CSV / CSA)
- 21 CFR Part 11-ready audit trails
- Requirement-to-release traceability
Expanding
Financial Services
The same discipline applied to regulated, documentation-heavy financial software — where controls and change records are non-negotiable.
- Documented, defensible change control
- Model & system evidence for examiners
- Segregation of duties across agent roles
Approach
Two ways to work with us.
Option A
The platform
Run the agent-first SDLC inside your own environment. Your teams direct the work; the agents build, validate, and produce the compliance record continuously.
Explore the platformOption B
Productized build sprints
Fixed scope, fixed timeline. We deliver a defined, validated piece of software — with its complete audit-ready package — on a schedule you can plan around.
Scope a sprintAbout
“Compliance stopped being a phase the moment we let the agents own it end to end.”
OneCliq is built by a focused founding team with deep experience in pharma, quality, and enterprise consulting — people who have lived the validation burden from the inside and built the SDLC they wished existed.
FAQ
The questions regulated teams ask.
Yes. The SDLC is designed to run inside your own infrastructure, including on-premises and air-gapped deployments, so code and data never leave your control. Deployment topology is confirmed during discovery.
Your source, data, and validation artifacts stay within your environment and permission model. Access is scoped and logged, agent actions are recorded, and we align to your existing security and governance controls rather than replacing them.
Artifacts are produced as a by-product of the work itself. As agents plan, build, and validate, they emit linked requirements, specifications, executed test evidence, and change records — assembled continuously into a validation package rather than written up afterward.
It means documented evidence that the software does what the requirements say, and only that — traced from specification through executed testing to release, in a form your quality function and an external auditor can review. The methodology is designed to fit your existing SOPs and validation approach.
Yes. Your teams set requirements, review, and approve. The agents do the work and produce the evidence; sign-off and accountability remain with your people. Human review gates are configurable at each step.
Schedule discovery
See what validated-in-weeks looks like for your team.
A short discovery call to map one regulated workflow and the compliance record it would generate.