Get A Laboratory Quality Handbook of Best Practices & Relevant PDF

By Donald C. Singer

ISBN-10: 0873894901

ISBN-13: 9780873894906

ISBN-10: 087389491X

ISBN-13: 9780873894913

Booklet through Singer, Donald C.

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Media and hardcopy listings of all table structures, methods, procedures, libraries, forms, and graphics a. System requirements b. User requirements c. Training requirements d. Development methodology 2. Network software 3. Operating system software 4. Software versions tested 48 Part II: Critical Laboratory Operations B. Hardware 1. Hardware configuration, operating instructions, wiring diagrams, and cabling requirements a. Network architecture and cabling descriptions b. Network hubs, routers, and connectors c.

Clearly identify who did what and when. • Define what signatures mean. • Only the facts on paper/electronic media count. • Rumors and thoughts mean nothing. KEY WORDS • Document control • Data • Standard operating procedure • Raw data *The author appreciates the contribution of Mr. A. P. Hart in reviewing this chapter. 27 • Logbooks 28 Part II: Critical Laboratory Operations In any regulated industry, documentation can provide evidence of conformance with regulatory authorities’ expectations.

The need for such an SOP is evidenced by the variations in quality and quantity of data and information recording, corrections, and cross-referencing. There is a legal and patent basis for defining the recording of research data, which is usually covered by a company document and may also be described in every laboratory notebook. This is outside the scope of this chapter and the reader is strongly advised to check with senior management or the company attorney for further information. Chapter Five: Laboratory Documentation and Data 31 DATA RECORDING The following sections will describe key points of the SOP content covering documentation principles.

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A Laboratory Quality Handbook of Best Practices & Relevant Regulations by Donald C. Singer


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