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A discussion is provided of system documentation and writing a validation summary report for spectrometry software. A system description is needed because it is a regulatory requirement for the European Union, OECD (Organization for Economic Cooperation and Development), and the Pharmaceutical Inspection Convention/Scheme, Guidance for Inspectors on Computerized Systems in GXP Environments. The system has to be written, approved, and controlled. Types of personnel who could participate in a validation are instrument vendor staff, systems managers, users, consultants, and IT staff. Users have to know where to find current copies of documentation so they can do their jobs, and standard operating procedures (SOPs) are needed for operation of the software and the instrument, and an expert says there is a minimum list of a dozen SOPs required for operation of a computer system in a regulated or accredited laboratory. The SOP on SOPs should detail the approach taken to the writing of SOPS within the functional group, sections, which can authorize the procedure, a description of the procedure, and distribution list. Also discussed are SOPs for preventive maintenance, control of environmental conditions, change control and configuration management, contingency plans and emergency operation, security, installation and updating of software, and development and updating of system software procedures.
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