Information and documentation requirements

1 The list of the information and documentation that may be used to implement a SIS, includes  

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NOTE 1 For examples of documentation structure, see lEC 61508-1 Annex A and, for more details, lEC 61506. 

NOTE 2 The documentation could be available in different forms (for example, on paper, film or any data medium to 

1 The documentation required by this standard shall be available. 

3 The documentation shall have unique identities so it shall be possible to reference the 

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The EU published and later modified their guidelines for submission of variations to marketing applications. These guidelines list the type of changes that can be submitted as Type I (minor) variations, and contain the necessary information and documentation required to support the proposed change. A number of the defined Type I (minor) variations... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

As shown in Figure 1.5 and described in Section 1.4, the design and engineering of a chemical process requires the co-operation of many specialist groups. Effective cooperation depends on effective communications, and all design organisations have formal procedures for handling project information and documentation. The project documentation will include ... 

The past resistance to the validation of APIs is that much of the required information and documentation should be contained within the scope and requirements of a successfully completed DMF. A DMF document, however, does not have the legal weight of the CGMP regulations, which provide the basis for requiring API validation documentation. 

The user s needs are analyzed in order to determine appropriate prospective solutions. The prospective solutions are high-level solutions identifying major constraints, system interfaces, user interfaces, and proposed technologies. These solutions are also used to assess the criticality and complexity of each proposed system component (refer to Appendix D for more information). This assessment will provide information on the resources and documentation requirements for the project. 

Historic aerial photographs provide the accuracy and documentation required to compile a precise record of site boundaries, points of access, and adjacent land use. Engineering borings for construction projects in the vicinity of suspected sites are integrated with geologic information to construct reasonable hydrogeologic models to evaluate potential leachate impact on water wells or nearby inhabitants. 

The clinical batch record should be reviewed for GMP compliance and documentation requirements. The biobatch and stability batch records should be reviewed for equivalence to the information included in the NDA/ANDA submission. Process controls, specifications, bioequivalence data, and other information supported with foreign data should be submitted with a certified translation of that data. 

The paper on which this book is printed meets the requirements of ISO 9706 1994, Information and documentation - Paper for documents -Requirements for permanence . 

Once all the stakeholders agree that the objectives document accurately describes the desired functions and objectives for the product or system, the next step is to develop the requirements document. The purpose of this document is to identify aU information and control requirements associated with each... 

ISO (2003). ISO 11799 2003 Information and documentation — Document storage requirements for archive and library materials. International Organization for Standardization. 

As a result all safety relevant information and documentation as required for the procurement and construction phase is available. 

However, third parties in terms of this clause are neither employees of the contract partner, nor professional consultants or experts who are required to have knowledge about confidential information and documents for the execution of the contract. Contractor and employer will bind the parties mentioned above by confidentiality. 

Employee safety training efforts shall be documented in compliance with the Hazard Communication and Laboratory Standards information and training requirements. The documentation shall include the following information ... 

Once a toller has been selected and any required preliminary confidentiality protection is in place, the client typically shares more detailed information. The toller can then make an informed decision about the economic, technical, and safety aspects involved in bidding the work. If the two parties decide the project will be mutually beneficial, agreements and obligations are negotiated and then formalized in a written contract. Both parties—the client and the toller—have roles in fulfilling the contract and in carrying out their responsibilities to the workers and the public. The purpose of the written contract is to clarify and document those roles and responsibilities to effectively execute, maintain and eventually terminate the project. 

The scope includes carnage of dangerous substances by wagons, large containers, small containers and tanks. Cover the documentation requirements, the mode of transport, the information needs, loadmg/unloadmg, security, safety... 

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