TESTA Analytical has released 21CFR Part 11 compliance software for use with its 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 tightly regulated and highly audited sectors such as the pharmaceutical industry. In such environments, quality control techniques comply with laws and guidelines by providing detailed documentation about the process, methods used, operator activities and performed validation on the instrumentation.
Easy-to-use new 21CFR Part 11 compliance software can assign lab personnel specific roles that are password protected to ensure that measurements can be tracked to a specific user. It fulfils 21CFR Part 11 compliance requirements by including the ability to log activities by user and preventing any manipulation of data. Offering detailed documentation of activities and operations, backed by a powerful database, this software package is designed to provide a valuable tool in labs where reliability of results is paramount.
Compliance software should be complimented by regular performance validation by external experts to ensure that all aspects of instrument use are in accordance with manufacturer specifications. Recently audited by a major pharmaceutical lab - TESTA Analytical 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.
For further information please visit https://www.testa-analytical.com/particle-sizing-instruments.html or contact TESTA Analytical on +49-30-864-24076 / info@testa-analytical.com.
