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Copyright Title
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Status
Published
on 9 May 2008
Year of Creation
2008
Copyright Claimant
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Registration Number
TX0006992958
on 9 May 2008Copyright Summary
The U.S. Copyright record (Registration Number: TX0006992958) dated 9 May 2008, pertains to an electronic file (eService) titled "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems" created in 2008. The copyright holder is International Society for Pharmaceutical Engineering, Inc. (ISPE), known for their creative contributions in text registration. For any inquiries concerning this copyrighted material, kindly reach out to International Society for Pharmaceutical Engineering, Inc. (ISPE).
Copyright Details
Copyright Claimant
International Society for Pharmaceutical Engineering, Inc. (ISPE)
Application Details
Registration Number
TX0006992958
Registration Date
5/9/2008
Year of Creation
2008
Agency Marc Code
DLC-CO
Record Status
New
Corporate Author
ISPE GAMP Community of Practice Committees
Physical Description
Book, 352 p. + CD-ROM
First Publication Nation
United States
Preexisting Material
GAMP Guide for Validation of Automated Systems - GAMP 4
Corporate Authors
Notes
Material Matter Claimed Note: Revision and new content
Previous Registration Note: 2002, TX-5-500-101
Statements
Application Title Statement: GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Author Statement: ISPE GAMP Community of Practice Committees employer for hire Domicile: United Kingdom Citizenship: United Kingdom
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