Life cycle Document Management Systems

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

There are two questions most commonly faced by validation organizations "What do we validate " and "How does validation differ from normal project activities such as Factory Acceptance Testing and Site Acceptance Testing " The answers are that we validate GxP critical aspects of the system, i.e., those aspects that can have a direct or indirect impact on product quality, safety and efficacy. Validation is essentiaily a term used to denote the additional rigor applied to the management and documentation of the each phase of the development and operational life cycle of the system. 

Analytical trees can be used in a variety of ways in the system safety effort. The most common application of analytical trees in current system safety programs is probably the use of fault trees for fault tree analysis (FTA). However, analytical trees can also be used as planning tools, project description documents, status charts, and feeder documents for several hazard analysis techniques (including fault tree analysis). Analytical trees can be multipurpose, life cycle documents and represent one of the most useful tools available to managers, engineers, and safety professionals. 

Looking at this document life cycle from the perspective of a pure paper-driven laboratory, it can be seen that a significant amount of work is generated by the purely manual execution of these steps. For organizations that already operate an electronic document management system (DMS), there is the advantage that all steps can be conducted highly automated and with a minimum of effort, that is, media breaks can be avoided, consequently. 

In conclusion, while RAD projects offer many advantages, they also pose certain risks, and thus require careful, competent, realistic management to ensure that they deliver validated computer systems. RAD must not be used as an excuse to circumvent necessary life-cycle controls and documentation. 

The validation summary report brings together all of the documentation collected throughont the whole of the life cycle and presents a recommendation for management approval when the system is validated. The emphasis is on using a summary report as a rapid and efficient means of presenring results as the detail is contained in the other documentation in the validation package (see Chapter 11 for more details). 

Enables gaps in existing management system and documentation to be addressed early in the project life cycle... 

One of the major factors to be considered when implementing a GxP-compliant EDMS is validation. The basic validation approach is no different from that applied to other information management systems such as MRP 11 or Laboratory Information Management Systems (LIMS). An approach based on the validation life cycle in GAMP is appropriate. Figure 34.3 shows how validation documentation relates to typical project activities. Validation permeates all stages of the implementation process, as described below. 

In addition to validating each individual imported document a check should be made to ensure that all required documents have been imported. Failure to do this could result in critical documents being missing from the EDMS. As part of this hnal check the documents should also be checked to see that the EDMS contains the current version of all the documents in question in case documents have been updated since import. On completion of this validation step in a full life-cycle system the management of the documents in question should then be transferred to the EDMS. 

There are often many thousands of project documents for MRP II systems. They should all be subject to document (life-cycle) management including following approval processes, indexing, and archiving. Document management must cover the implementation project, operation, and maintenance of the system. 

In addition to the European GMP Guide, Pharmaceutical Inspections Convention Scheme (PIC/S) has an impact on pharmaceutical companies situated mainly in Europe. The Pharmaceutical Inspections Convention Scheme tries to harmonize inspections across the member countries. Therefore, even if the documents are not legally binding, they will be used by inspectors to measure companies against. This organization published in 2003 a new guidance document for the life-cycle management of computerized systems. 

For a system managing documentation pertaining to the full life-cycle of drug development, including the conduct of clinical trials, a useful cabinet and folder hierarchy might resemble the following ... 

Version Security. In the paper world, archival documents held in a file room are in some sense final drafts. Security for a product document must be determined by its status. The electronic document management environment in which documents are managed across their entire life cycle by its very nature allows for the inclusion of draft materials. So, in addition to permitting or disallowing the viewing of the final version of a file, the electronic world must consider and secure access to draft versions. Usually, only authors, editors, and reviewers of files have access to the drafts before they are finalized. Once files are promoted to final status, this version is then promulgated to a broader readership. The draft versions, by contrast, may continue to be accessible by the authors, or may be locked or purged from the system. 

Most of the system safety effort involves providing a service. That service is to identify, analyze, and control hazards as early in the life cycle as possible in order to produce cost-effectively a safer end product. Several products are produced as part of the system safety effort. These products (all documents) communicate and document risk information to management and provide a means of monitoring and auditing the effort. 

All regulatory agencies adopt what amounts to a life cycle approach to developmental and operational control of computerized equipment, with emphasis on documentation of software development and quahty management especially in GLP environments. The life cycle for analytical instruments from the user s perspective includes the purchasing phase (including system/vendor qualification), the IQ, OQ and PQ phases of AIQ (Section 9.5.1a), the maintenance phase and, fmaEy, the retirement phase, which probably occurs more frequently with respect to computers and software than the analytical instruments... 

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