By Donald C. Singer
E-book via Singer, Donald C.
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Extra resources for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
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. Network interface cards and performance data d. Network servers e. Network printers f. Prime server’s power backup VI. Testing Description A. Testing procedures for determining functionality, limits, ranges, etc. 1. Test data 2. Test results 3.
Documentation should be established describing written design specifications, including the intended use and methods for achieving the intended use. A protocol should be written based on the design specifications. Documentation should be made of test results and an evaluation of the results demonstrating that the design specifications have been met. Further discussion of the validation of software is described under the section on validation. Written procedures need to be in place to cover computerized system changes.
The data generated in this method may need to be printed and then signed by the operator. Examples may be sterilizer logs or stand-alone thermocouple devices. Periodic maintenance of the LIMS hardware should be done on the computer network hardware, including testing and inspection. Document the operations performed and record the results. ” Additionally the FDA specified in the Guidance for Industry; Computerized Systems Used in Clinical Trials (1999) that the “FDA may inspect documentation, possessed by a regulated company, that demonstrates validation of software.