Technologies supporting Part

PAPER-BASED VERSUS ELECTRONIC-BASED SOLUTIONS 

The record requirements discussed in Chapter 22 apply to both hard-copy records and to electronic records. The privacy, authenticity, reliability, and nonrepudiation mechanism used in a traditional paper-based solution consist of  

Privacy Authenticity Reliability Nonrepudiation Envelopes Notaries, strong ID, physical presence Signatures, watermarks, barcodes Signatures, receipts, confirmations 

The privacy, authenticity, reliability, and nonrepudiation mechanisms used in a digital-based solution consist of  

Electronic-based solutions can be used to support the security requirements contained in Part 11. The following sections in this chapter provide an overview of the main electronic-based solutions necessary to achieve trustworthy records, and to securing computer resources to manage these records. 

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The authors (RS, CD and MSD) thank the International Joint Research Program of the New Energy and Industrial Technology Organization (NEDO), Japan for their support. Part of the work by RS is supported by a Grant-in-Aid for Scientific Research (No. 09243211) from the Ministry of Education and Science of Japan. The MIT work was partly supported by the NSF (DMR 95-10093). 

Chapter 24 discusses how hashing, encryption, and digital signature technologies can be used to support Part 11. 

O.Lopez, Technologies Supporting Security Requirements in 21 CFR Part 11, Part I, Pharmaceutical Technology, February 2002. 

This project has been supported partly by a grant for Development of Systems and Technology for Advanced Measurement and Analysis (SENTAN) from the Japan Science and Technology Agency (JST) from the Ministry of Education, Culture, Science, and Technology, Japan (http //www.jst.go.jp/ sentan/en/)... 

A. Sage for technical support. Part of the research described was carried out at the Jet Propulsion Laboratory, Califonria Institute of Technology, under a contract with the National Aeronautics and Space Administration. 

This work was supported partly by the Pennsylvania State University, partly by the Army Research Office under Contract DAAL 03-92-G-0118, and partly by the California Institute of Technology Multidisciplinary University Research Initiative under ONR Grant No. N00014-95-1-1338. The authors are indebted to Dr. Yeong Chemg (John) Liau for his contributions in developing the RDX ignition and combustion models. 

T. O. thanks Dr. Y. Ozawa for helpful and stimulating discussions. This work was supported partly by Core Research for the Evolutional Science and Technology, Japan Science and Technology Corporation. Japan Synchrotron Radiation Research Institute is also acknowledged both for financially supporting the installation of the instrument and for the assignment of beam-time. 

This work was supported partly by the Ministry of Education, Culture, Sports, Science and Technology of Japan (Grant-in-Aid for Basic Research No. 14205121 and for Scientific Research on Priority Areas 417) and the Japan Science and Technology Agency. 

The authors thank A. Cherstvy for theoretical calculations, S. Ingebrandt for valuable discussions, and M. Abouzar for technical support. Part of the work was supported by the Ministerium fiir Innovation, Wissenschaft, Forschung und Technologic des Landes... 

TY thanks Dr. Olaf Karthaus and Dr. Masatsugu Shimomura for stimulative discussion. This research has been supported partly by the Shorai Foundation for Science and Technology. 

This work was supported partly by a Grand-in-Aid for Science Research (A) (No. 12305055) from the Ministry of Education, Science, Sport, and Culture, Japan and partly by the ERATO-Itaya Electrochemis-copy Project organized by the Japan Science and Technology Corporation (JST). 

The work presented in this paper was partly supported by the National Science and Technology Support Plan of China under the Grant No. 2012BAK10B06-2, and Natural Science Foundation of China (NSFC) under the Grant No. 41030749. 

M. Baer would like to thank the Israeli Ministry of Science and Arts and the German Ministry of Science and Technology for partly supporting the research reported here under grant No. E1447. 

Acknowledgements The author is indehted to Prof. Zdenik Friedl from the Chemical Faculty of the Brno University of Technology for his participation in solving some partial problems of the initiation reactivity of EMs, to Assoc. Prof. Pavel Vdvra from the Institute of Energetic Materials and to Assoc. Prof. Josef Panchartek from the Department of Organic Chemistry, both from the University of Pardubice, for their valuable remarks on this paper. This material is based upon work supported partly by the Ministry of Industry and Trade of the Czech Republic as part of its Research project STRATECH No. FC-M2/05/00 and partly by the Ministry of Education, Youth and Sports of the Czech Republic as part of its research project No. MSM 0021627501. 

We would like to thank Debbie de la Cruz and GE Infrastructure and Chris Plotz and BHA Technologies for giving us the GE E500A microporous polysulfone support and the BHA microporous Teflon support, respectively. We would also like to thank the National Science Foundation, the Office of Naval Research, and The Ohio State University for the financial support. Part of this material is based upon work supported by the National Science Foundation under Grant No. 0625758. 

Membranes. Membranes comprised of activated alumina films less than 20 )J.m thick have been reported (46). These films are initially deposited via sol—gel technology (qv) from pseudoboehmite sols and are subsequently calcined to produce controlled pore sizes in the 2 to 10-nm range. Inorganic membrane systems based on this type of film and supported on soHd porous substrates have been introduced commercially. They are said to have better mechanical and thermal stabiUty than organic membranes (47). The activated alumina film comprises only a miniscule part of the total system (see Mel rane technology). 

Seeing the success of the UNAMAP BBS, EPA s Office of Air Quality Planning and Standards started a BBS for information on regulatory models in June 1989. This has expanded to a BBS called TTN, Technology Transfer Network. This BBS, in Durham, NC, is reached on (919) 541-5742 and the system operator on (919) 541-5384. A part of this BBS called SCRAM, Support Center for Regulatory Air Models, contains model FORTRAN codes, model executable codes for use on personal computers, meteorological data, and in some cases model user s guides. Much of the information is downloaded in "packed" form, and software to unpack the files must also be downloaded from the bulletin board. 

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