Organizational interfaces documenting

The standard requires that organizational interfaces between different groups which input to the design process be identified and the necessary information documented. 

How do you identify, document, transmit, and regularly review the organizational and technical interfaces between different design groups ... 

Organizational and technical interfaces between different groups are identihed, and the necessary information is documented, transmitted, and regularly reviewed. 

The fourth major section of the business plan is the operational structure and processes. In brief, this section describes how the program will be run. This section of the document should provide details on how the service will be provided and by whom—in other words, the work processes that will occur. It should include information on how customers will interface with the program. The organizational structure, number and types of employees, and equipment and other resources used in operation of the program should be described. This section should also include definitions of the regulatory, clinical, and quality requirements that may be applicable to the business and a description of how these requirements will be met. 

The excipient manufacturer should develop plans that identify the responsibility for each design and development activity which is updated as necessary. Organizational and technical interfaces between different groups should be identified and the necessary information documented, transmitted and regularly reviewed. 

Contract companies do not work in isolation—they have organizational and physical interfaces with the operator of the offshore facility and with other contractors. Since each company will have its own SMS, bridging documents are needed. A bridging document is a map that links the relevant sections of the different standards. So, if the operator s plan calls for start-up procedures, then the bridging document would show where the same information is located in the contractors documents. Any gaps would be identified, and the contractor s program would be modified to ensure that it fits with the operator s requirements. 

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