“Our platform can’t miss a beat.”
Managed maintenance, upgrades, and dictionary cycles that keep Argus and connected systems reliable and current — without pulling your team off case work.
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Solutions built around the outcome you own.
We don’t sell hours against a task list. We start with the result you’re accountable for — an on-time submission, a clean inspection, a platform that finally connects — and engineer back from there.
Solutions by outcome
Four problems we’re brought in to solve.
“We need to modernize without risk.”
Validated cloud migration and integration work that lowers cost and manual effort while protecting reporting continuity and data integrity.
“An inspection is coming.”
Part 11 remediation, right-sized validation, and inspection-ready evidence that stands up to FDA, EMA, and MHRA scrutiny.
“We can’t see our own data.”
Consolidated reporting layers and dashboards that turn fragmented case data into governed, decision-ready insight for leadership and signal teams.
How we deliver
A four-stage method, engineered for regulated systems.
Because these platforms are validated and inspected, every stage produces the evidence and controls the next one depends on.
Stage 01
Assess
We map your current safety platform, integrations, dictionaries, and compliance posture — and pin down the outcome and constraints.
Stage 02
Design
We propose a right-sized, risk-based plan with clear validation strategy, rollback, and timelines aligned to your reporting obligations.
Stage 03
Deliver
We execute inside your windows — building, migrating, integrating, and testing — with traceable evidence produced as we go.
Stage 04
Sustain
We hand over documentation and training, then provide managed support or step back — whichever leaves your team strongest.
Engagement models
Work with us the way that fits your team.
Project delivery
A defined scope — an upgrade, a migration, an integration, a validation package — delivered to a fixed plan with clear acceptance criteria.
Managed safety operations
Ongoing ownership of maintenance, dictionary cycles, monitoring, and support under an SLA, so your platform is simply always handled.
Embedded specialists
Senior Argus and validation consultants working alongside your team for a defined period, augmenting capacity where you need it most.
Advisory & assessment
A focused review of your safety systems, compliance posture, or roadmap — with a prioritized, practical set of recommendations.
Audit trail coverageComplete
E-signature controlsEnforced
Access review cadenceQuarterly
Data-integrity modelALCOA+
Last inspection outcomeNo findings
Compliance woven in
Every solution ships inspection-ready.
Compliance isn’t a phase at the end — it’s a property of how we build. Controls, evidence, and traceability are produced continuously, so you’re never scrambling before an audit.
- Mapped to the regulation. Controls tied directly to 21 CFR Part 11 and Annex 11 clauses.
- Evidence as you go. Validation and change records generated during delivery, not reconstructed after.
- Ready to defend. We stand with you in the inspection room when it counts.
Bring us the outcome. We’ll bring the plan.
A short scoping conversation is usually enough for us to tell you what’s achievable, in what timeframe, and how we’d approach it.
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