Expert Validation Services

In industries such as pharmaceuticals, biotechnology, and medical device manufacturing, equipment validation isn’t optional, it’s fundamental. Providing documented evidence that critical equipment, especially temperature-controlled units, is installed correctly, operates as intended, and consistently performs to specification is essential for compliance and quality assurance. We offer Expert Validation Services, specializing in IQ, OQ, and PQ protocols executed to the highest standards, ensuring your equipment meets FDA and international guidelines.

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Validation is a systematic process conducted in three distinct phases:

  • Installation Qualification (IQ): This initial phase verifies and documents that the equipment, along with its sub-systems, has been delivered, installed, and configured correctly according to manufacturer specifications, design documents, and safety regulations. Key IQ activities include verifying model numbers, checking utility connections (power, etc.), ensuring correct location and environmental conditions, confirming software installation (if applicable), and collecting essential documentation (manuals, calibration certificates).

  • Operational Qualification (OQ): Following successful IQ, OQ tests and documents that the equipment operates correctly throughout its specified operating ranges, as defined in user requirement specifications and manufacturer guidelines. OQ typically involves testing critical functions like control system operation, alarm functions, temperature stability and uniformity, security features, and safety interlocks.

  • Performance Qualification (PQ): The final phase, PQ, verifies and documents that the equipment consistently performs according to specifications under actual operating conditions, often with a representative load, over a period of time. PQ demonstrates reproducibility and suitability for the intended process. Activities may include loaded temperature mapping studies, testing under simulated real-world use (e.g., door openings), and verifying performance consistency across multiple runs.