TESTA Analytical announces new 21CFR Part 11 compliance software for use with its popular family of NanoBrook instrumentation for particle sizing and zeta potential.
Determination of particle size and zeta potential are commonly used measurement techniques for the quality control of materials in sectors such as pharmaceuticals, which are highly regulated and monitored. In such environments, quality control techniques must comply with a wide range of laws and guidelines by providing detailed documentation of the entire process, methods used, operator activities and validation performed on the instrumentation.
The powerful, yet easy-to-use new 21CFR Part 11 compliance software can assign laboratory personnel specific roles that are password protected to ensure that measurements taken are traced to a specific user. The new software also meets the requirements to comply with 21CFR Part 11, including the ability to log user activities and maintain data integrity by preventing any tampering. This software package provides detailed documentation of all activities and operations, supported by a powerful database, and is a valuable tool for all those laboratories where the reliability of results is paramount.
However, compliance software alone is not sufficient to comply with regulations. This should be supplemented with regular performance validations by external experts to verify that all aspects of the instrument’s use are in accordance with the manufacturer’s specifications.
Recently Verified by a Major Pharmaceutical Laboratory: TESTA Analytical offers a complete portfolio of validation services, including IQ/OQ/PQ (and MQ if necessary), for all users of NanoBrook Series instruments operating under 21 CFR 11 regulations.