Hanwell Instruments
FDA Compliance  
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21 CFR Part 11 covers:

° Electronic records
° Electronic signatures
° Handwritten signatures to electronic records
° Records that have been created, modified, maintained, archived, retrieved or transmitted.

Certification applies to Hanwell Instruments Limited, United Kingdom only.


Food and Drugs Administration - FDA Compliance Procedure

Hanwell Instruments Limited (UK), established in 1990 by university research scientists, provides integrated data acquisition systems to pharmaceutical organisations throughout the world, 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 pressures. Hanwell has secured an enviable reputation for reliable data acquisition systems, with a bespoke design and installation service available. All of our equipment is designed and manufactured by us in the UK, with direct access to our design team being a key feature of our approach.

At Hanwell we recognise that integrity of data is crucial to all pharmaceutical and associated industries and accordingly we strive to supply only high quality instrumentation with a fully compliant support infrastructure. Careful attention to sensor and software design have helped Hanwell to many ‘firsts’ with innovative procedures and products.

The UK pharmaceutical industry, incorporating biotechnology, is the second largest contributor to Gross Domestic Product, second only to the financial sector, with annual exports of over £5,500 million and continually increasing its share of global business. Five of the world’s top 20 best-selling drugs were developed in British laboratories using advances in modern technology, creating new opportunities in the treatment of diseases throughout the world. The practical application of this hard-won knowledge in a manufacturing environment requires careful attention to precision, not only in terms of the instrumentation hardware, but also the associated data handling.

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 trail tracking of systems records and signatures, as stated in the Good Clinical Practices Predicate Rules, are of critical importance in clinical data. Hanwell is committed to manufacturing systems compliant with these requirements, offering the 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 supporting documentation for each component.

In addition Hanwell undertakes to keep constant pace with the latest advancements and FDA compliance guidelines, assuring clients of a sustained growth path.

Hanwell Instruments Limited has offices throughout Europe and North America, offering the best in data acquisition products for professional users, 24 hour comprehensive support services and direct communication with design specialists.

Hanwell Instruments Limited is an ISO registered company.


    Hanwell Russia | TE Moscow | 11 Skakovaya Alleya | Moscow 127287
    Tel: +7 (495) 660-86-30 | Fax: +7 (495) 335-59-02 | Mobile: +7 (495) 792-14-65 | Russia E: hanwell@hanwell.ru