Pharmaceutical information systems maintenance

Information systems for managing proprietary research information are an important component of all research programmes. Pharmaceutical companies devote significant resources to the development and maintenance of internal information systems for use in all phases of the research process. Information management in the lead finding and lead optimisation phases of research is a topic of particular importance that has received considerable attention during the last decade. 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

The output of the FMEA analysis is paramount to the determination of the business risk (consequence of function failure) presented by a system. This risk is used to determine the level of rigor applied to the validation, operational control, maintenance, and documentation/information needed to verify and maintain system performance as indicated by Figure 31.5. It follows that the documentation/information supporting system functions is as critical to the pharmaceutical organization as the system function itself. 

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