Implementation of LIMS

The International Standards Organization 9000 (ISO 9000) standard, developed by the European Economic Community (EEC), also impacts manufacturers implementation of LIMS systems. ISO 9000 is a set of standards which are required for manufacturers selling products to the EEC. The 9000 standards are credited with playing an important part in the impetus to greater computerization of laboratory information management (9). 

The hardware and software used to implement LIMS systems must be vahdated. Computers and networks need to be examined for potential impact of component failure on LIMS data. Security concerns regarding control of access to LIMS information must be addressed. Software, operating systems, and database management systems used in the implementation of LIMS systems must be vahdated to protect against data cormption and loss. Mechanisms for fault-tolerant operation and LIMS data backup and restoration should be documented and tested. One approach to vahdation of LIMS hardware and software is to choose vendors whose products are precertified however, the ultimate responsibihty for vahdation remains with the user. Vahdating the LIMS system s operation involves a substantial amount of work, and an adequate vahdation infrastmcture is a prerequisite for the constmction of a dependable and flexible LIMS system. 

The implementation of LIMS requires a significant amount of investment in capital money and manpower. There are large numbers of established vendors that provide commercial LIMS with a similar range of core functionality, but... 

The implementation of LIMS should not be performed without fully assessing its impact in the wider context of how it will be integrated into the laboratory business processes and how it will impact on existing laboratory staff s ways of working. 

Another problem is that implementation of LIMS usually includes changes in work procedures, responsibilities, and many other things. This may influence both the old and the new ways of working as well as the quality of the result. 

However, there are two other implementations that are possible with a LIMS, which result in different position of the interface between the laboratory and organization. Figure 2 shows the more common implementation, which is probably typical of the majority of early implementations of LIMS in the 1980s. The main functions carried out by the system are the same as that discussed previously but the emphasis of the implementation is different. The... 

System Analysis, Catalog of Duties, Selection, and Implementation of LIMS... 

The business activity of the organi2ation dictates quaUty requirements for the LIMS. Security and regulatory requirements for LIMS data define the level of effort expended to vahdate a LIMS and the data being stored. In addition, the quahty of the hardware and software used to implement the LIMS both play a role in determining overall system quahty. 

Lloyd et al.1 described automation processes for compound optimization and simultaneous implementation of (1) a LIMS system to automate and track the flow of sample information, data analysis, and reporting (2) an automated data archiving system to handle a large number of LC/ MS/MS data files (3) custom software to track a large number of protocol flows and (4) workstation automation. 

Multiple locations sharing the design for their own implementation of a common application (e.g., LIMS, Distribution Systems, and common DCS)... 

LIMS is now a mature technology, and many packages are commercially available. Therefore, this chapter will concentrate on the selection, configuration, and implementation of a LDVtS in a pharmaceutical manufacturing environment, rather than the development of in-house software for laboratory management. 

Fundamental to the snccessfnl implementation and validation of LIMS is to understand the roles and interactions between the three main gronps contribnting to the project. These gronps are ... 

Supplier The gronp that sells the LIMS application. As the developer of LIMS, it is expected that the snpplier has in-depth technical knowledge of the product and has experience in its implementation system. 

Customer The gronp reqniring the implementation of the validated LIMS. Customers will have varying levels of expertise, experience, and resonrce availability to contribnte to the implementation and validation. 

A complicating factor in the validation of LIMS is the wide variety in the scale of LIMS implementations. A LIMS can vary from a PC-based application in a single laboratory to a client/server-based system running across multiple sites on a company-wide area network with shared access to servers and multiple interfaces to other business systems. 

It must be clearly understood, and covered in the business case, that the implementation and initial validation of LIMS is only one component of the cost of the system through its life. Installation is just the beginning of an ongoing commitment to the maintenance of LIMS in a validated state. This includes the commitment to the ongoing cost of maintenance of the system, infrastructure, and business processes. 

The justification to senior management that LIMS is a cost-effective solution. These Business Requirements will be the basis for applying for funding for purchase and implementation of the application. The owner of LIMS must understand the benefits and drawbacks of implementing LIMS prior to purchase the requirements definition is the only time in the project that it can be achieved at a reasonable cost. 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

Examples exist of systems implemented only a few years ago for which replacement parts and software enhancements are no longer available, let alone the relevant software skills to make one s own bug Axes or developments. Choices mnst be made whether to upgrade in an evolutionary way, taking into acconnt the cost of buying and implementing the next generation of LIMS, or to upgrade... 

The implementation of an effective security regime is required to comply with the regulators expectations for control of electronic records. The pharmaceutical manufacturer will be responsible for providing maintenance of the security aspects of LIMS. This is normally accomplished through software protection (e.g., passwords and log-on accounts) but may also take the form of protection through physical restrictions (e.g., locked-up or restricted areas). The management of this function should be in accordance with a formal SOP. The use of passwords and high-level accounts must be strictly controlled to prevent security breaches. Typical examples of control should be ... 

This article describes what a Laboratory Information Management System (LIMS) is and provides a discussion on building vs. buying a LIMS. It also discusses the cost of a LIMS system, how to write a user requirements specification (URS), how to assess the vendors answers to the URS, the implementation of the system, and the organization around a LIMS system. 

First we discuss VBA, a powerful development environment used directly from within the Microsoft Office suite of programs. Typically, Word or Excel is most frequently used, since many LIMS and instrument software directly export reports in these formats. One of the primary advantages with VBA is the rich, intuitive object model that is provided by each of the Microsoft Office applications. The implementation of VBA as a cost-effective and first-line approach to data automation in drug discovery has been reported [76]. Bisset s book entitled Practical Pharmaceutical Automation contains many examples of Excel VBA in the laboratory setting [67]. 

It has been mentioned already that there are different levels of sophistication with regard to the involvement of computer applications in GLP studies and test facilities. These levels may range from the complex problems involved in the GLP compliant management of computer networks and of laboratory information management systems (LIMS) to the question of whether a simple instrument controlled by a built-in, pre-programmed chip should be treated in the same, extensive way with regard to software validation . It is certainly self-evident, as these two examples demonstrate, that not all types of IT applications have to be considered as equal with regard to GLP compliance it may indeed be impossible to do so. As it is commonplace nowadays that the silicon chip penetrates the operation of practically all kinds of work, the elucidation of its involvement in the operations of test facilities becomes an essential part of the implementation of GLP. 

The acquisition of a LIMS is a strategic purchase for a laboratory. The implementation of a LIMS impacts not only the existing IT environment but also the existing workflow and the philosophy of how laboratory processes are performed. As a result, laboratory organizations have to face various problems when implementing a LIMS. 

Implementation of digital signatures for long-term data and database contents (e.g., archived or LIMS data). 

One of the attractive and also risky features of the implementation of a LIMS is that it can be done rapidly. This will, therefore, reduce the amount of time available for ensuring that the appropriate "quality" is built into the system, which is especially the case when implementing a replacement LIMS. The simple answer is that the pharmaceutical manufacturer must ensure that a "quality supplier" is being used for the LIMS. This is easy to state but difficult to do there are many suppliers on the market who will advise that their systems are the best and that they are also The pharmaceutical manufacturer must take appropriate steps such as performing a Supplier Audit, following up references and so on before any decision is made. 

It has been shown many times that just because the LIMS supplier is ISO 9000 accredited does not mean the supplier is a quality supplier of software products. This is because the LIMS supplier is often accredited for the implementation and integration of LIMS, rather than the development of software. In these cases, the only way of gaining confidence in the approach to be taken in the software development, testing and change control processes is to visit the LIMS supplier s premises. Where a supplier is accredited to ISO 9000-3 (TickIT), this will give the manufacturer greater confidence that a defined life cycle is followed because it is specifically aligned with the production of software. 

The DQ process begins as soon as the URS has been produced and then effectively continues until the implementation of the LIMS in terms of hardware, software and database configuration. The objective of the DQ is to ensure that a high-quality system is ultimately installed, thus giving the pharmaceutical manufacturer a system in which there is a high level of confidence. Quality can only be built into the design and implementation of the LIMS it cannot be tested in afterward. DQ should therefore be considered as the development of the project, following which the project will move into... 

The implementation of an effective security regime is very important to ensure that unauthorized personnel do not access the LIMS data. Threats can come from external sources, for example, "hackers" via the Internet/ networks, and from viruses. 

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