By Donald C. Singer
E-book by way of Singer, Donald C.
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Additional info for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
Computer printouts 13. Certificates of analysis 14. Charts 15. Forms 16. Memos 8. Equipment maintenance records 17. Out-of-specification investigations 9. Specifications 18. 1 Change in the types of documents and their content detail. Documentation is only as good as the procedures and training that support it. A company needs to have a standard operating procedure (SOP) which describes in suitable detail the writing, issuance, and maintenance of documents. In larger companies there is usually a corporate document (policy) that describes, in general terms, documentation commonly found, but this is usually based on legal, patent, and business requirements.
The computerized system validation protocol may contain a summary with the following checklist or outline: I. Introduction (defines the scope of the validation) II. Justification (defines the agency or compliance documents under which the validation is run) III. Name of the person that developed the protocol and the date IV. Regulatory References V. System Description A. Software 1. Media and hardcopy listings of all table structures, methods, procedures, libraries, forms, and graphics a. System requirements b.
The biometric system is based on recognition of a person based on distinguishing traits. Electronic signatures using biometrics must be designed to be unique to their owners. The electronic system is based on at least two distinct identification components, such as an identification code and password. Typically LIMS applications have a log-in event consisting of a user name, initials, or identifier, as well as a password. The execution of one of the two electronic signature components may constitute a log-in.