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GLP/GMP Computer Procedures and Systems
Author: Donald L. Crone
Publisher: CRC / Interpharm Press
Copyright: February 1995
ISBN: 0-935184-74-0
Price: $239.00 (US dollars)

Author Donald Crone is Director of Data Management and Statistical Services for Biotechnical Services, Inc., a consulting company specializing in data management and documentation services for the biotechnology industry. He has 25 years of experience as an information services manager, serving 14 of those years in regulated industries.

Crone offers a binder of practical information rather than a book, utilizing this format to enable the user to create a complete GLP/GMP computer procedures system. There are 91 standard operating procedures (SOPs) to cover "everything you need to know and do to have regulatory compliant hardware and software. The 91 SOPs, numerous forms and flow charts become your instant computer documentation system, providing every detail needed to establish and run your computer system in a GMP compliant manner."

The binder format was used to allow photocopying and immediate adoption. SOPs are available on a 3.5" IBM PC compatible disk (included with the binder) in WordPerfect 5.0 and ASCII for importing into the user's own computer.


To order, or for more information, contact:
CRC Press LLC
2000 NW Corporate Blvd
Boca Raton, FL 34431 USA
Telephone: +1 800-272-7737 or +1 561-994-0555
Facsimile: +1 800-374-3401 or +1 561-989-9732
   
 
Bookshelf