Document Manager

Stores hazmat information generates documents and reports MSDS document management. 

A primary objective of any safety program is to maintain or reduce the level of risk in the process. The design basis, especially inherently safer features that are built into the installation, must be documented. Management of change programs must preserve and keep the base record current and protect against elimination of inherently safer features. For identical substitution, the level of risk in the process is... 

The basis for your program plan should be your team s assessment of the current PSM status (Figure 4-11), which will have yielded a list of deficiencies compared with the required PSM elements. These gaps must now be translated into statements of required tasks, which in turn suggest work products for inclusion in your implementation plan. For example, your assessment shows that the process knowledge and documentation management system needs improvement. To address this gap you need to plan a series of tasks. 

At the strategic level, boiler water treatment practice is essentially the planned, actioned, and documented management of the waterside of pre-boiler, boiler, and post-boiler plant equipment and systems. A key objective is to identify, obtain, and maintain operational and economic benefits for the plant owners, including maintaining the cleanliness and structural integrity of the boiler, its various water-steam cycle auxiliaries, and other components for a specified (long-term) period and to some quantifiable standard. 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

Links to document management system for regulatory reports and submissions... 

Employee believed he was using the correct version of the procedure, but due to defects in the document management system, he was using an out-of-date edition... 

Use a good document management system and stress to the team that almost any document generated may become part of the public record. 

Document management Change control N onconformances Corrective and preventative actions Biological product deviation Product disposition Validation Production Manufacturing Process monitoring... 

Modem cooling water treatment practice is the planned, actioned, and documented management of cooling systems to produce and maintain operational and economic benefits for the users. 

Document management and control—to ensure the availability of current approved documentation and an audit trail of all records related to the validation program... 

The design of control and monitoring instrumentation and regulating devices should be based on an established document management system that enables preparation to be formally approved, implemented, recorded, and audited. Typical contents and document deliverables of an integrated engineering documentation system are as follows ... 

An efficient document management and control system is essential for minimizing the costs of a process validation effort. Detailed discussion of document management is beyond the scope of this chapter however, one suggestion is offered that has proven particularly successful. Efficiency of the document review and approval process can be greatly enhanced by a policy that defines the purpose of each signature required (e.g., technical correctness, regulatory compliance, compliance with other corporate documents, and authority to pro-... 

An existing and documented management of change process is followed during the... 

The focus of the validation program is usually the quality attributes of the system implementation, change control, and the verification and testing of modifications made to the baseline system. The configuration management of the system, including its documentation, is a key area of concern. Specifically, documentation management is extremely critical for the information contained in both the master production records, and in the application. 

E-mail is probably the most widespread ready-made application where electronic signature can be used and is used. Work flow and document management applications are other examples of information systems where an electronic signature is needed. Those applications are mainly dedicated to closed communities of users and documents with a limited validity period. The paperless office is the type of application that may be most promising for coming years. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

Division Files System (DFS). DFS is the cornerstone of the administrative management of files initiative. It provides document management, tracking, archiving, and electronic signature capabilities for internally generated review documents. It also provides search and retrieval capabilities for final versions of internally generated review documents. 

DIA Electronic Document Management Meeting, February 13, 2003 (Posted February 24,2003)... 

Electronic Submissions to the FDA, Randy Levin, MD, Fifth Annual Electronic Document Management Conference, September 23, 2002 (Posted November 14, 2002)... 

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