Validation, Compliance & Documentation
AIS Vision Automation supports manufacturers in regulated environments by delivering systems that meet compliance standards. Our validation and documentation services ensure systems are qualified, traceable and audit-ready.
Supporting Regulated Industries
We work with industries where precision, traceability and compliance are mandatory, including medical devices and pharmaceutical production.
Our processes align with regulatory expectations and industry best practice.
Validation Services
We provide structured validation support as part of system delivery:
Installation Qualification (IQ)
Verifies the system is installed correctly and documented.
Operational Qualification (OQ)
Confirms the system operates as intended across its full operating range.
Performance Qualification (PQ)
Demonstrates the system performs consistently in real production conditions.
Built for Regulated Environments
Our systems and processes are designed to align with:
- GMP (Good Manufacturing Practice) environments.
- Medical device regulations (ISO 13485, FDA, MDR).
- Pharmaceutical quality standards.
- Client-specific validation protocols.
Every system is delivered with a complete, audit-ready documentation set:
- IQ, OQ and PQ protocols and signed reports.
- Design, build and test records.
- Traceability and calibration certificates.
- Operating and maintenance manuals.
We help you stay prepared for regulatory audits and customer inspections:
- Documentation structured for easy review.
- Clear traceability from specification to validation.
- Support during audits and inspections.
Validation continues across the working life of your system:
- Re-qualification after changes or upgrades.
- Periodic review and revalidation support.
- Ongoing maintenance of validated status.
