Validation for the systems that run your labs and production floor — LIMS, MES, SCADA, chromatography data systems and instrument software — risk-based, Part 11-compliant and inspection-ready.
What we validate
From sample login to batch release, we validate the GxP systems your operations depend on.
LIMS
Laboratory information management — sample, result and specification workflows validated for integrity.
MES
Manufacturing execution — electronic batch records and production workflows.
CDS
Chromatography data systems — the classic data-integrity hotspot, validated and controlled.
SCADA / control
Supervisory control and data acquisition for regulated processes.
Instrument software
Qualified instrument systems and their data handling.
Integrations
Validated flows between lab, manufacturing and quality systems.
What you receive
- System-specific validation plan
- User & functional requirements
- Risk-based IQ/OQ/PQ protocols
- Data-integrity (ALCOA++) evidence
- Audit-trail and access-control verification
- Vendor qualification leverage
- Traceability matrix
- Audit-ready validation summary report
Where data integrity is won or lost. Lab and manufacturing systems are the most-cited DI areas — we validate them with that scrutiny in mind.
Validated operations, end to end
Scope
Inventory systems, instruments and integrations.
Assess
Risk-classify and leverage vendor evidence.
Validate
IQ/OQ/PQ focused on high-risk functions.
Sustain
Requalification and change control.
Why teams choose us
Operations fluency
We understand CDS, LIMS and MES behavior — not just validation theory.
Data-integrity first
The areas inspectors cite most are where we focus.
CSA-efficient
Risk-based testing, vendor-leveraged where justified.
Senior, defensible
Named consultants behind every deliverable.
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteValidate your lab and manufacturing systems
Tell us which systems are in scope. We’ll scope a fixed-fee validation plan.
Request a Quote






