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Equipment Validation Services for Regulated Environments

Alpha Controls provides comprehensive equipment validation services for regulated industries where compliance, accuracy, and data integrity are non-negotiable. We support a wide variety of industries including pharmaceutical, biotech, laboratory, and manufacturing facilities with validation solutions that stand up to audits, inspections, and real-world operational demands.

Our validation programs are designed to ensure reliable process performance and ongoing regulatory compliance, aligned with global and industry standards including ISO, cGMP, WHO, USP, ISPE, ASTM, ICH, and Health Canada requirements.

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Compliant Equipment. Defensible Results.

All equipment used for our validation services are fully compliant with applicable regulatory and industry standards. This ensures accurate, repeatable, and auditable results you can trust, whether you’re validating a single system or an entire facility.

With Alpha Controls, validation isn’t just about checking a box, it’s about confidence in your data, your processes, and your compliance.

What We Can Validate

Alpha Controls validates a comprehensive range of equipment and facility systems across regulated industries. Our validation services cover everything your operation requires ensuring each piece of equipment performs reliably, meets regulatory standards, and is fully documented for audits and inspections.

Thermal Equipment

We provide IQ/OQ/PQ and requalification services for thermal equipment including: 

  • Autoclaves
  • Dry heat ovens
  • Vacuum ovens
  • Incubators

Our validation ensures precise temperature control and reliable sterilization performance, with fully audit-ready documentation that meets GMP and ISO compliance requirements.

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Temperature-Controlled Storage

We provide seasonal temperature mapping services for:

  • Warehouses
  • Refrigerators
  • Walk-In/Reach-In Freezers
  • Ultra-low temperature freezers
  • Cold rooms

Our validation confirms year-round performance across all storage environments, protecting product integrity and delivering fully documented verification that meets regulatory compliance requirements.

Stability & Environmental Chambers

We provide comprehensive validation services for:

  • Stability chambers
  • Photo stability chambers

Our validation verifies that temperature, humidity, and light conditions remain precisely controlled and consistently within specification. Accurate environmental conditions are critical for reliable stability studies and shelf-life testing, and our validation ensures your chambers perform as expected while delivering fully documented, audit-ready results that support ongoing regulatory compliance.

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Speciality & Safety Equipment

We provide validation services for:

  • Narcotic vaults
  • Biosafety cabinets
  • Downflow booths

This ensures containment and safety systems perform reliably in high-risk and controlled environments. Our validation supports personnel protection and secure material handling, delivering thorough documentation that meets the rigorous compliance standards these critical environments demand.

Cleanroom & Facility Systems

We provide comprehensive validation services for:

  • Cleanroom and production suite qualification
  • Environmnetal monitoring systems
  • Non-viable particle counters

We verify that temperature, humidity, and pressure differentials meet strict performance requirements. Our validation ensures environmental conditions align with ISO and GMP standards, supporting accurate cleanroom classification and reliable ongoing facility monitoring with fully documented, audit-ready results.

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