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Validation of chromatography data systems : meeting business and regulatory requirements / R.D. McDowall.
- Format:
- Book
- Author/Creator:
- McDowall, R. D.
- Series:
- RSC Chromatography Monographs
- RSC chromatography monographs
- ISSN
- Language:
- English
- Subjects (All):
- Chromatographic analysis.
- Computer software--Validation.
- Computer software.
- Physical Description:
- 1 online resource (289 p.)
- Edition:
- 1st ed.
- Place of Publication:
- Cambridge : Royal Society of Chemistry, c2005.
- Language Note:
- English
- Summary:
- Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the
- Contents:
- Validation of Chromatography Data Systems_publicity; 00-8190; 01-8191; 02-8192; 03-8193; 04-8194; 05-8195; 06-8196; 07-8197; 08-8198; 09-8199; 10-8200; 11-8201; 12-8202; 13-8203; 14-8204; 15-8205; 16-8206; 17-8207; 18-8208; 19-8209; 20-8210; 21-8211; 22-8212; 23-8213; 24-8214; 25-8215; 26-8216; 27-9079
- Notes:
- Description based upon print version of record.
- Includes bibliographical references and index.
- ISBN:
- 9781615833726
- 1615833722
- 9781847552297
- 1847552293
- OCLC:
- 647959285
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