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Why You Can't Skip Validation

Validation is more than a regulatory requirement; it’s proof that your equipment and storage systems operate safely, accurately, and reliably. In the pharmaceutical and life sciences industries, equipment and storage units must perform reliably according to manufacturer specifications and regulatory standards. 

Key Benefits of Validation

  • Ensures GMP Compliance
  • Provides documented proof of equipment reliability
  • Reduces risk of product quality issues
  • Supports regulatory inspections and audits

Without validation, you risk inconsistent product quality, safety issues, and regulatory non-compliance. Alpha Controls ensures that every qualification study and mapping exercise delivers accurate, validated results, giving your team confidence that your equipment and processes are operating exactly as intended. Our goal is to help your business achieve consistent product quality, safety, and compliance.

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Our Validation Services

Alpha Controls offers a complete suite of validation solutions, including IQ/OQ/PQ protocols, equipment mapping, calibration, and software validation. Our services are designed to support a wind range of industries: pharmaceutical, chemical, cannabis, cosmetic, aerospace, and automotive.

Consultation & Preliminary Assessment

Every study starts with collaboration. Our experts work hand-in-hand with your team to assess system design, compliance expectations, and performance objectives which helps set the stage for a seamless validation process. 

This includes:

  • Phone or virtual consultations to review your validation needs
  • On-site assessments of equipment, environment, and processes
  • Trial mapping or trial runs to verify equipment readiness before formal studies
Consultation
Protocols

IQ/OQ/PQ Protocol Development & Execution

Our team delivers end-to-end validation services across the full equipment lifecyle, including:

  • Installation Qualification (IQ):  Ensures equipment is installed correctly.
  • Operational Qualification (OQ): Confirms equipment operates according to specifications.
  • Performance Qualification (PQ): Demonstrates consistent performance under normal operation conditions.
  • Requalification and periodic validation
  • Seasonal temperature and environmental mapping (summer and winter), where required

We execute protocols using validated software packages such as Fluke TQ-Soft, MadgeTech 4 Secure, and Kaye AVS Validator to ensure 21 CFR Part 11 compliance for electronic data collection.

Precise Calibration Services

Validation often requires calibration of equipment sensors, loggers, and control instruments. 

Alpha Controls provides:

  • Three-point calibration using high-accuracy reference standards
  • Issuance of ISO/IEC 17025-compliant calibration certificates for all instruments used in validation studies
  • On-site and in-lab calibrations of instruments including:
    • Fluke temperature thermometers
    • KAYE products
    • Rotronic handheld units
    • And more!
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21 CRF Part 111

Software Validation & Compliance

Many commercially available instruments are 21 CFR Part 11 compliant, but they are not IQ/OQ validated for your specific process. Alpha Controls ensures your software is properly validated, providing documented proof of data integrity, traceability, and regulatory compliance.

Specialized Equipment Validation

  • High Temperature & Humidity Stability Chambers:
    • Validation for conditions up to 70 °C and 90% RH
  • Ovens & Furnaces:
    • Heat treatment validation up to 1100 °C, compliant with AMS2750 Temperature Uniformity Studies.
  • Cryogenic & Ultra-Low Temperature Freezers:
    • Validated probes to -196 °C and ULT freezers to -86 °C.
  • Autoclaves:
    • Steris, Getinge, and other models, including heat distribution, penetration analysis, and equilibrium time validation with 1-second intervals.
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Why Choose Alpha Controls For Your Validation Services?

Choosing the right partner for equipment and process validation can make the difference between a smooth, compliant project and costly delays or regulatory challenges. At Alpha Controls, we combine decades of experience, industry-leading technology, and a results-driven approach to provide unmatched validation and calibration services for the pharmaceutical, life sciences, and highly regulated industries.

With Alpha Controls, you gain a partner who understands the regulatory landscape, provides expert guidance, and delivers auditable, reliable documentation for every validation project. Our team’s hands-on experience with high-temperature ovens, cryogenic freezers, autoclaves, and stability chambers ensures your processes are validated with precision every time.

Decades of Industry Expertise

Our team brings over 100 years of combined experience in validation, calibration, and quality assurance. Each team member has hands-on expertise in IQ/OQ/PQ protocols, equipment mapping, and software validation, ensuring that your projects are handled with precision and professionalism. We understand the unique challenges of each system and can provide custom solutions tailored to your equipment and processes. 

Client-Focused, Customized Solutions

Every project is unique.

We collaborate with your team to develop validation plans that are:

  • Practical and efficient
  • Fully aligned with regulatory requirements
  • Tailored to your operational needs

Our extensive experience and proven methodologies have made Alpha Controls a trusted partner for companies seeking reliable validation, calibration, and qualification services.

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Discover More About Validation on Brand's Brands

A Deep Dive into the Kaye Validator AVS - Brand's Brands Episode 26

Warehouse Mapping 101: What, Why and How? - Brand's Brands Episode 17

Temperature Mapping: Nail it Every Single Time - Brand's Brands Episode 15