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By Donald C. Singer

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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.

Logical security can be addressed on the network. The networked LIMS or computerized systems may be secured in a number of different ways depending on the operating systems and the networking software. All access to the network server is typically controlled via an individual user name and password. File access rights are established by the network manager or the file owner and may only be modified by system management personnel. Only computer system management personnel are assigned rights to modify or control the network operating system.

Testing conclusions 6. Formal release VII. Documentation A. Standard Operating Procedures B. Validation Documents C. System-related Documentation D. Testing Documentation VIII. Validation Report A. List all required SOPs for LIMSs B. List all documentation C. List all archived and updated software and documentation D. List all operator documentation E. Attach all validation protocols F. List all software versions validated G. Summary of test conclusions Chapter Six: Sample Control and LIM Systems 49 ELECTRONIC DATA SYSTEM AUDITS Computer systems are monitored and audited to ensure that they comply with the good automated laboratory practices (GALPs).

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