RECORD-KEEPING AND DOCUMENTATION

The normal practice is to designate a single person on the incident investigation team to coordinate photography. This person works closely with the team member responsible for documentation and record keeping and coordinates with other groups outside the team. 

Schohes J. Documentation and record-keeping in chnical prachce. 

The storage, trade and distribution of pharmaceutical products are carried out by various companies, institutions and individuals. The nature of the risks involved, however, is likely to be the same as those in the manufacturing environment, e.g. mix-ups, contamination and cross-contamination. There are thus aspects of distribution to which the principles of GMP should be applied. These include, but are not limited to, storage, distribution, transportation, packaging, labelling, documentation and record-keeping practices. 

Included in this element are requirements for purchasing documents (specifications, drawings, and purchase orders), selection of suppliers, inspection and control of received material and record-keeping. For ESH/PSM, this element would focus on those aspects of the procurement process which support purchasing according to regulatory requirements, safety standards, risk management controls, etc. 

In many circumstances, the supplied system will be based on a standard COTS product and include additional features that are superfluous in the intended context. These features cannot normally be disabled because they are integral to the COTS product. Such redundant features should be included in the Functional Specification, noted as superfluous and, if possible, rendered inaccessible to users within the implemented computer system. Standard features that support compliance, such as audit trails for electronic records, should be used even if not defined within the URS. In such circumstances it may be necessary to make additional design allowances for the inclusion of these features (e.g., for audit trail functionality, extra storage capacity may be required). Standard documentation for COTS products can be referenced by the Fnnctional Specification, if available for inspection, rather than reproduced. Care must be taken to refer to the correct version of COTS documentation and to keep cross-references up to date following any system upgrades. 

Documentation requirements of tlie calibration and record keeping... 

The National Advisory Committee s Hazard Analysis and Critical Control Point (HACCP) program has been endorsed as an effective and rational means of assuring food safety from harvest to consumption [8], The basic principles used to develop a HACCP plan include hazard analysis, verification procedures, critical control point identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record keeping and documentation. This same approach could be loosely applied to the identification and control of microbiological hazards encountered by consumers in their environment. 

Management s responsibilities, commitments to quality and process review Quality policy, processes and planning Gathering and review of requirements Document management, version control and record keeping The design and development processes, inputs and outputs Verification, validation, monitoring and test activities... 

Readiness reviews sometimes identify problems with respect to documentation and records. During the constmction and commissioning of a plant, there is usually considerable pressure just to get the plant completed and up and mnning. Hence the record-keeping part of the project may slip. If, in the judgment of the review team, some of the missing documents are important to safety, then the team must insist that those documents are completed and issued before the plant is started. 

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