Enbloc can provide a comprehensive range of integrated data acquisition systems to the Pharmaceutical, Electronics and Healthcare environments, with particular emphasis on radio telemetry solutions. The benefits of wireless technology in either a laboratory or manufacturing environment are self evident and there is now great interest in the application of such equipment, particularly for the routine monitoring of slowly changing variables such as Temperature, Humidity and Differential Pressures. Enbloc have secured an enviable reputation for reliable data acquisition systems, which have been incorporated into many of our cleanroom projects. We recognise that the integrity of data is crucial to all Pharmaceutical and associated industries and strive to supply only high quality instrumentation with a fully compliant support infrastructure.
We can offer sensors which can continually monitor and log a vast array of parameters including:
Electronic systems, transmitting and collecting data, are now subject to the most stringent administrative controls as laid down in 21 CFR Part 11 (Control of Federal Regulations) by the Food and Drug Administration (FDA). These controls continue to be refined with each technological advance.
21 CFR Part 11 covers electronic records, electronic signatures, handwritten signatures executed to electronic records and requires each to be reliable, trustworthy and generally equivalent to paper records and handwritten signatures executed on paper. It applies to records that have been created, modified, maintained, archived, retrieved or transmitted.
Audit trial tracking of system records and signatures, as stated in the Good Clinical Practices Predicate Rules, are of critical importance in clinical data. Enbloc are committed to manufacturing systems compliant with these requirements, offering tools which will allow the client to validate the system in the context of their own business. These tools include Validation Workbooks, Simulation Software and Support Documentation for each component.
Our systems will keep constant pace with the latest developments and FDA compliance guidelines, assuring clients of a sustained growth path.
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