Documentation life cycle

In 1983 the FDA issued what became known as the Blue Book (because of the color of its cover). This publication gave guidance to inspectors on what was reasonable to accept as validation evidence for computer systems. The Blue Book formally introduced the expectation of a documented life-cycle approach to validation. The aim was to build quality into software from the earliest stages of the life cycle (quality assurance) rather than vainly trying to test quahty in at the end (quality control). 

Be developed according to a defined, documented life cycle of adequate scope and depth that ensnres the structural integrity of the delivered software and facilitates its testing and maintenance... 

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. 

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. 

Documents have a life cycle from creation to destruction. In the paper world, we take for granted that each physical instance of a document is created, distributed, archived and destroyed. In the paperless world, it is also important to decide what steps the document life cycle consists of, i.e., what stages a document can be in—"created", "reviewed", "approved" and "archived" as an example (see Figure 1.2). 

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 general, for regulated documents, document life cycle applies (see Figure 8.2) ... 

Figure 8.2 Document life cycle of regulated documents.

Does your company have a documented product stewardship policy, or a health, safety and environmental policy which incorporates the management of chemicals through their total life cycle, thus minimizing adverse effects on human health and well-being and on the environment If so please attach. ... 

The typical deliverables of a development cycle (see Pattern 15.13, Interpreting Models for Clients) are not individual completed documents from the linear life cycle. More usually, they might be first draft requirements GUI mockup client feedback second draft requirements critical core code version 1 requirements modified to what we find we can achieve ... 

Process control documents (PCDs), 26 745 Process control languages (PCL), 20 672 Process control system, 20 730-731 Process cut-offs, in life cycle assessment, 24 813... 

Much of the process knowledge and documentation is developed through the earlier life cycle stages of a facility. Most of these components need to be retained or kept up to date during the entire facility lifetime. 

Compatibility. See incompatible materials Compliance, audits, 114—115 Concept stage, life cycle issues, 20-23 Consequence analysis, risk assessment, 91 Corporate memory, documentation,... 

Category 4—Configurable Software Packages These software packages can be conhgured according to user requirements. A supplier audit is usually required to conhrm software has been developed according to a documented quality system. Validation should ensure software meets URS requirements. Full life cycle vahdation is needed. 

If we create a repository and make it too bulky, the chances of getting useful information actually decrease with time. So, there is this trade-off. . . Also, we are implementing many shorter life-cycle projects nowadays - 6 weeks to 3 months duration. Suppose someone searches the repository, gets three documents, takes 2 to 3 days to read them and then finds that they are not useful. This is a considerable waste of time. If this happens, this person might question the very utility of the repository and decide not to use it in the future. 

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

Proof of allelopathy could be strengthened if more research was done to document uptake and fate of allelochemicals in the recipient or suscept plant. We need to determine relative toxicides (selectivity) of allelochemicals on the target species. What might be the outcome of a 30% growth reduction during only 2 weeks of a plant s life cycle ... 

Company). The product of the FEL process is a design-basis package of customized information used to support the production of detailed engineering design documents. Completion of the FEL design-basis package typically coincides with project AFE (Authorization for Expenditure) or project authorization. Project authorization is that point in the project life cycle where the owner organization commits the majority of the project s capital investment and contracts. 

The Registration phase of REACH and the Principles of Chemical Leasing business models have additional central aspects in common. They both involve different stages of the supply chain - as producers and applicants are challenged - and both approaches are life-cycle oriented either through their documentation requirements addressing phases of production, use or dis-... 

Adolescents. Documentation of the safety and efficacy of antidepressants and mood stabilizers is better for adolescents than for children, although not at the standard for adults. That is unfortunate, because mood disorders often have their onset in adolescence, especially in girls. Not only do mood disorders frequently begin after puberty, but children with onset of a mood disorder prior to puberty often experience an exacerbation in adolescence. Synaptic restructuring dramatically increases after age 6 and throughout adolescence. Onset of puberty also occurs at this time of the life cycle. Such events may explain the dramatic rise in the incidence of the onset of mood disorders, as well as the exacerbation of preexisting mood disorders, during adolescence. 

For new applications or projects a prospective validation based on a recognized life cycle is the most effective and efficient approach. The life-cycle methodology can also be adapted for existing systems that do not have adequate documented records to support a retrospective validation. 

Industry groups and regulatory authorities have debated and addressed the issues surrounding computer system validation, with the PDA [4] and GAMP Forum [3] providing industry guidance on validation life-cycle methodology and documentation. 

Furthermore, the ISPE Baseline Guide, Commissioning and Qualification [5] emphasises the need to undertake qualification practices only for equipment and system component parts and functions that could directly impact quality attributes of a product or process. Other components and functions are to be dealt with under good engineering practice (GEP) [3,5] throughout the system life cycle, undergoing an appropriate level of documented commissioning. 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

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