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Compressed Air Testing

Ensuring compressed air meets required quality and purity standards.

ISO 8573-1 purity classes • ISO 8573-7 test methods
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cGMP Validation

Documenting and demonstrating that processes, equipment, and systems consistently meet cGMP requirements.

IQ/OQ/PQ • FDA cGMP • EU GMP Annex 15

Data Integrity Lifecycle

Ensuring data remains accurate, complete, consistent, and reliable throughout its lifecycle.

ALCOA+ principles • FDA data-integrity guidance • Applicable 21 CFR Part 11 requirements
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Environmental Monitoring

Monitoring environmental conditions to ensure controlled areas meet required quality standards.

EU GMP Annex 1: sterile operations • ISO 14644-2: cleanroom particle monitoring
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Temperature Mapping

Assessing and documenting temperature distribution and consistency across a controlled environment.

GMP temperature-mapping guidance • Defined storage conditions
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Documentation

Maintaining accurate, complete, and traceable records to demonstrate compliance with pharmaceutical and food quality requirements.

EU GMP Chapter 4 • 21 CFR Part 211 records and reports: applicable pharmaceutical work
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