Compliance Software and IQ/OQ/PQ Services for Particle Sizing

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Making analytical measured in a regulated environment.

Making analytical measured in a regulated environment.

TESTA Analytical's new 21CFR Part 11 compliance software can be used with its popular family of NanoBrook particle sizing and zeta potential instrumentation.

Determination of particle size and zeta potential are widely used measurement techniques for quality control of materials in sectors such as the pharmaceutical industry which are tightly regulated and highly audited. In such environments – quality control techniques have to comply with a wide range of laws and guidelines by providing detailed documentation about the whole process, methods used, operator activities and performed validation on the instrumentation.

The powerful, yet easy-to-use new 21CFR Part 11 compliance software can assign lab personnel with specific roles that are password protected to ensure that the measurements performed are tracked to a specific user. The new software also fulfils requirements to be compliant to 21CFR Part 11 including the ability to log activities by user and maintain the integrity of data by preventing any manipulation of it. Offering detailed documentation of all activities and operations, backed by a powerful database, this software package is a valuable tool for all those labs where reliability of results is paramount.

However, compliance software alone is not sufficient for complying with regulations. This should be complimented by regular performance validation undertaken by external experts to check that all aspects of use of the instrument are in accordance with manufacturer specifications.

Recently audited by a major pharmaceutical lab - TESTA Analytical Solutions offers a complete portfolio of validation services including IQ/OQ/PQ (and if required MQ), for all users of NanoBrook Series instruments operating under 21 CFR 11 regulations.

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