LIMS, MES and manufacturing systems validation
Bringing a new LIMS or MES into production? Lab and manufacturing systems are where data integrity is won or lost. We validate them with a focus on high-risk functions.
The challenges this solves
Our lab systems draw the most findings
Chromatography data systems and LIMS are frequent data integrity hotspots.
Integrations are a blind spot
Data moves between lab, manufacturing and quality systems without validated flows.
IQ/OQ/PQ takes too long
Every function gets the same testing, whatever its risk.
What we deliver
- LIMS: sample, result and specification workflows validated for integrity
- MES: electronic batch records and production workflows
- Chromatography data systems (CDS)
- SCADA and control systems for regulated processes
- Qualified instrument software and its data handling
- Validated integrations between lab, manufacturing and quality systems
- Audit-trail and access-control verification
Systems and tools
- Rockwell FactoryTalk PharmaSuite MES
- Waters Empower
- Siemens TIA Portal
- AVEVA Edge
- Vaisala viewLinc
- Labguru
4 steps, clear deliverables
- 01
Scope
Inventory systems, instruments and integrations.
You receive: System-specific validation plan
- 02
Assess
Risk-classify systems and leverage vendor evidence.
You receive: User and functional requirements
- 03
Validate
Run IQ/OQ/PQ focused on high-risk functions.
You receive: IQ/OQ/PQ protocols, ALCOA++ evidence and traceability matrix
- 04
Sustain
Maintain control through requalification and change control.
You receive: Audit-ready validation summary report
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
Related services
Questions we hear most
Which systems do you validate?
LIMS, MES, CDS, SCADA and control systems, instrument software, and the integrations between them. See our list of validated systems for named products.
Do you still use IQ/OQ/PQ under CSA?
Yes. Protocols are risk-based, focus on high-risk functions and leverage vendor evidence where justified.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing. Scope scales to your systems and goals.
Validate your lab and manufacturing systems
Get a scoped, fixed-fee quote for your systems and integrations.