Automation and validation of information in pharmaceutical processing:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Dekker
1998
|
| Series: | Drugs and the pharmaceutical sciences
90 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XII, 445 S. graph. Darst. |
| ISBN: | 0824701194 |
Staff View
MARC
| LEADER | 00000nam a2200000 cb4500 | ||
|---|---|---|---|
| 001 | BV012281546 | ||
| 003 | DE-604 | ||
| 005 | 00000000000000.0 | ||
| 007 | t | ||
| 008 | 981126s1998 d||| |||| 00||| eng d | ||
| 020 | |a 0824701194 |9 0-8247-0119-4 | ||
| 035 | |a (OCoLC)231764946 | ||
| 035 | |a (DE-599)BVBBV012281546 | ||
| 040 | |a DE-604 |b ger |e rakddb | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-12 | ||
| 245 | 1 | 0 | |a Automation and validation of information in pharmaceutical processing |c ed. by Joseph F. DeSpautz |
| 264 | 1 | |a New York [u.a.] |b Dekker |c 1998 | |
| 300 | |a XII, 445 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 90 | |
| 650 | 0 | 7 | |a Datenverarbeitung |0 (DE-588)4011152-0 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Automation |0 (DE-588)4003957-2 |2 gnd |9 rswk-swf |
| 655 | 7 | |0 (DE-588)4143413-4 |a Aufsatzsammlung |2 gnd-content | |
| 689 | 0 | 0 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |D s |
| 689 | 0 | 1 | |a Automation |0 (DE-588)4003957-2 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a Pharmazeutische Industrie |0 (DE-588)4045696-1 |D s |
| 689 | 1 | 1 | |a Datenverarbeitung |0 (DE-588)4011152-0 |D s |
| 689 | 1 | |5 DE-604 | |
| 700 | 1 | |a De Spautz, Joseph F. |e Sonstige |4 oth | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v 90 |w (DE-604)BV000002008 |9 90 | |
| 856 | 4 | 2 | |m GBV Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008325781&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-008325781 | ||
Record in the Search Index
| _version_ | 1804126904426430464 |
|---|---|
| adam_text | AUTOMATION AND VALIDATION OF INFORMATION IN PHARMACEUTICAL PROCESSING
EDITED BY JOSEPH F. DESPAUTZ INCODE CORP. HERNDON, VIRGINIA M A R C E L
MARCEL DEKKER, INC. NEW YORK * BASEL * HONG KONG CONTENTS PREFACE HI
CONTRIBUTORS XI I. INTRODUCTION 1. INTRODUCTION 1 JOSEPH F. DESPAUTZ II.
SYSTEMS PLANNING FOR AUTOMATION 2. INFORMATION SYSTEMS PLANNING 5 COLMAN
O MURCHU 3. INFORMATION TECHNOLOGY PLANNING FOR ELECTRONIC BATCH RECORD
OPERATIONS 25 JOSEPH F. DESPAUTZ 4. HUMAN FACTORS AND INFORMATION
SYSTEMS 47 JAMES L. VESPER 5. INSTRUMENTATION AND PROCESS CONTROL SYSTEM
STRATEGY 59 DAVID J. ADLER 6. AUTOMATION LIFE CYCLE IS MORE THAN LOOKING
AT COST: IT S A NEW TOOL FOR COMPETITIVENESS 69 STEVEN B. WILLIAMS AND
DAVID J. ADLER 1. MANAGING THE MANUFACTURING CONTROL DOMAIN 81 SEAN M.
MEGLEY VII VIII CONTENTS 8. DISTRIBUTED CLIENT/SERVER-BASED BATCH
CONTROL SYSTEM APPLIED AS PART OF THE ENTERPRISE SOLUTION SUITE USING
TECHNOLOGY 107 BAHA KORKMAZ III. IMPLEMENTING AUTOMATION 9. A CIM
ARCHITECTURE FOR VALIDATED MANUFACTURING SYSTEMS 117 JOSEPH F. DESPAUTZ
10. SYSTEM IMPLEMENTATION PLAN FOR VALIDATED MANUFACTURING SYSTEMS 137
JOSEPH F. DESPAUTZ 11. ENHANCED REGULATORY COMPLIANCE USING
MANUFACTURING EXECUTION SYSTEMS 159 FREDERICK R. BICKEL AND RICHARD E.
BLANCHETTE 12. INVESTING IN EDUCATION AND TRAINING 169 JAMES L. VESPER
13. DOCUMENTING EDUCATION AND TRAINING 197 JAMES L. VESPER 14.
EVALUATION AND CERTIFICATION 205 JAMES L. VESPER IV. COMPUTER SYSTEMS
VALIDATION 15. GMP REGULATIONS AND COMPUTER VALIDATION 221 TERI STOKES
16. VALIDATION CONCEPTS FOR MANUFACTURING SYSTEMS 245 KENNETH S. KOVACS
AND JOSEPH F. DESPAUTZ 17. MANAGEMENT S ROLE IN COMPUTER VALIDATION:
POLICY AND PROCEDURES 261 TERI STOKES 18. ELECTRONIC RECORDS, ELECTRONIC
SIGNATURES, AND FDA REGULATION FINAL RULE 275 TERI STOKES 19. APPLIED
COMPUTER VALIDATION PLAN FOR MANUFACTURING EXECUTION SYSTEMS 281
FREDERICK R. BICKEL AND RICHARD E. BLANCHETTE CONTENTS IX 20. ONE
KEYBOARD POUNDER S VIEWS ON VALIDATION 293 JOSEPH A. HERCAMP 21. A
VALIDATION PLAN FOR PROCESS AUTOMATION 307 KENNETH S. KOVACS AND JOSEPH
F. DESPAUTZ 22. PERFORMANCE QUALIFICATION TESTING OF INTEGRATED MRP/MES
323 JOSEPH F. DESPAUTZ AND KENNETH S. KOVACS 23. LIFE CYCLE
DOCUMENTATION FOR MRP-MES-PCS INTEGRATION 347 JOSEPH F. DESPAUTZ AND
KENNETH S. KOVACS V. SUPPLY CHAIN AUTOMATION 24. RESEARCH AND
DEVELOPMENT AUTOMATION 359 JEFFREY S. GRAMM 25. PLANT DESIGN AND
ENGINEERING 367 JACK CONAWAY 26. LOGISTICS 387 JOSEPH J. KOWALSKI 27.
BRINGING DISTRIBUTED CONTROL SYSTEMS INTO THE WORLD OF CLIENT-SERVER
BATCH CONTROL 397 ANTHONY R. GONZALEZ AND MARK CASTRO 28. BATCH PROCESS
AUTOMATION 417 TEDDY H. TOM AND KENNETH S. KOVACS INDEX 433
|
| any_adam_object | 1 |
| building | Verbundindex |
| bvnumber | BV012281546 |
| ctrlnum | (OCoLC)231764946 (DE-599)BVBBV012281546 |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01689nam a2200409 cb4500</leader><controlfield tag="001">BV012281546</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">00000000000000.0</controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">981126s1998 d||| |||| 00||| eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0824701194</subfield><subfield code="9">0-8247-0119-4</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)231764946</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV012281546</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakddb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-12</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Automation and validation of information in pharmaceutical processing</subfield><subfield code="c">ed. by Joseph F. DeSpautz</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">New York [u.a.]</subfield><subfield code="b">Dekker</subfield><subfield code="c">1998</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">XII, 445 S.</subfield><subfield code="b">graph. Darst.</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">90</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Datenverarbeitung</subfield><subfield code="0">(DE-588)4011152-0</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Automation</subfield><subfield code="0">(DE-588)4003957-2</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="655" ind1=" " ind2="7"><subfield code="0">(DE-588)4143413-4</subfield><subfield code="a">Aufsatzsammlung</subfield><subfield code="2">gnd-content</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Automation</subfield><subfield code="0">(DE-588)4003957-2</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">Pharmazeutische Industrie</subfield><subfield code="0">(DE-588)4045696-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Datenverarbeitung</subfield><subfield code="0">(DE-588)4011152-0</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">De Spautz, Joseph F.</subfield><subfield code="e">Sonstige</subfield><subfield code="4">oth</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">90</subfield><subfield code="w">(DE-604)BV000002008</subfield><subfield code="9">90</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">GBV Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008325781&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-008325781</subfield></datafield></record></collection> |
| genre | (DE-588)4143413-4 Aufsatzsammlung gnd-content |
| genre_facet | Aufsatzsammlung |
| id | DE-604.BV012281546 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:24:52Z |
| institution | BVB |
| isbn | 0824701194 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-008325781 |
| oclc_num | 231764946 |
| open_access_boolean | |
| owner | DE-12 |
| owner_facet | DE-12 |
| physical | XII, 445 S. graph. Darst. |
| publishDate | 1998 |
| publishDateSearch | 1998 |
| publishDateSort | 1998 |
| publisher | Dekker |
| record_format | marc |
| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Automation and validation of information in pharmaceutical processing ed. by Joseph F. DeSpautz New York [u.a.] Dekker 1998 XII, 445 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 90 Datenverarbeitung (DE-588)4011152-0 gnd rswk-swf Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf Automation (DE-588)4003957-2 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Pharmazeutische Industrie (DE-588)4045696-1 s Automation (DE-588)4003957-2 s DE-604 Datenverarbeitung (DE-588)4011152-0 s De Spautz, Joseph F. Sonstige oth Drugs and the pharmaceutical sciences 90 (DE-604)BV000002008 90 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008325781&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Automation and validation of information in pharmaceutical processing Drugs and the pharmaceutical sciences Datenverarbeitung (DE-588)4011152-0 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd Automation (DE-588)4003957-2 gnd |
| subject_GND | (DE-588)4011152-0 (DE-588)4045696-1 (DE-588)4003957-2 (DE-588)4143413-4 |
| title | Automation and validation of information in pharmaceutical processing |
| title_auth | Automation and validation of information in pharmaceutical processing |
| title_exact_search | Automation and validation of information in pharmaceutical processing |
| title_full | Automation and validation of information in pharmaceutical processing ed. by Joseph F. DeSpautz |
| title_fullStr | Automation and validation of information in pharmaceutical processing ed. by Joseph F. DeSpautz |
| title_full_unstemmed | Automation and validation of information in pharmaceutical processing ed. by Joseph F. DeSpautz |
| title_short | Automation and validation of information in pharmaceutical processing |
| title_sort | automation and validation of information in pharmaceutical processing |
| topic | Datenverarbeitung (DE-588)4011152-0 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd Automation (DE-588)4003957-2 gnd |
| topic_facet | Datenverarbeitung Pharmazeutische Industrie Automation Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008325781&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT despautzjosephf automationandvalidationofinformationinpharmaceuticalprocessing |