• Compliance software and validation services for precision particle sizing
    21 CFR Part 11 compliance and IQ/OQ/PQ illustrative image.

Laboratory Products

Compliance software and validation services for precision particle sizing

Dec 14 2023

Testa Analytical has launched a new 21CFR Part 11 compliance software designed for its NanoBrook particle sizing and zeta potential instrumentation. Particle size and zeta potential determination are crucial quality control measures, especially in regulated sectors such as the pharmaceutical industry. The compliance software ensures adherence to 21CFR Part 11 guidelines, offering password-protected roles for lab personnel, activity logging, and data integrity maintenance to prevent manipulation.

This user-friendly software provides detailed documentation of processes, methods, operator activities, and instrument validation, making it a valuable tool for labs prioritising result reliability. However, compliance software alone isn't enough to meet regulations; regular performance validation is essential. Testa Analytical Solutions offers a comprehensive portfolio of validation services, including IQ/OQ/PQ (and, if required, MQ), ensuring NanoBrook instruments comply with 21 CFR 11 regulations.

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