Bespoke application software

GAMP Category 5 Software Custom (Bespoke) Application Software... 

Configurable application software usually includes custom configurable packages such as Manufacturing Resource Planning (MRP 11), Documentum , Maximo and so on. Validation of such systems requires an audit of the supplier and validation of any bespoke application software. 

Emphasis within the life cycle will change depending on whether computer hardware is bespoke or standard and also on the mix of software categories in which the application software falls. Table 5.2 and Table 5.3 outline the preferred validation approach toward different categories of software and hardware based on the risk the various categories of software pose. 

Bespoke Application Not applicable Not applicable Bespoke software... 

Comparing COTS Software Packages and Custom (Bespoke) Applications... 

Software (e.g., operating system, database, application software modules, data sets, bespoke/custom/standard software modules, etc.)... 

The above list is applicable for the core LIMS software modules, interface software, and any other bespoke/custom software utilized by the LIMS. The reviewed source code listings should be marked up with comments and identified issues and then signed as evidence of the review. 

Operating Systems Application Software Configuration Bespoke Code... 

Configuration/parameterization and new bespoke development of application software should be carried out in accordance with a software Quality Assurance System (see Figure 4.3). The diagram shows the following relationships ... 

Where the OCS has a standard interface to a particular Fieldbus and the number of installations is such that this can be deemed as standard feature, there is little need for software module testing. This is true of any Fieldbus interface to any control system. In a traditional scenario, where data need to be transferred via the OCS to a maintenance application or a laboratory analysis package, the actual transfer of the data needs to be fully tested as a bespoke application. 

COTS products have the same basic validation requirements as any other type of software. Typically, suppher audits are expected for critical and complex applications as discussed in Chapter 7. If an audit is conducted and progress with any significant corrective actions cannot be proven, then suitable alternative suppliers or sources of software should be sought, including bespoke/custom developments. 

Generally, widely distributed Off-The-Shelf (OTS) software is not considered to need Source Code Review if a reputable developer has produced it under an effective system of quality assurance and the product requires no more than an application parameter configuration. In most computer systems, therefore, Source Code Reviews are limited to custom (bespoke) software and configuration within OTS software products. 

Bespoke Element Developments Writing extra software to complement the standardized application. These modihcations may impinge on standard software stams, but cau be compensated by overall functional (black box) testing. Bespoke code must itself be fully validated, including strucmral (white box) testing. 

Validation of the database application will typically be based on custom/bespoke software. GAMP 4 recommends the following activities for this category of software ... 

Configurable Software Consider audit, validate application, and any bespoke code. 

A Software Design Specification (Figure 2.14) must be developed to document the requirements of the bespoke software application. Typically, the Software Design Specification defines the software architecture in modular terms. 

There is always a question concerning the degree of testing that needs to be carried out in complex solutions. To a large extent, this depends on the application s "pedigree", aiticality and amount of bespoke software. 

The use of object-oriented software has been estimated to save literally millions of dollars on new plants, and these savings only estimate the savings in actual engineering hours. These savings will obviously be reflected in the reduced cost associated with vaiidating standard objects as opposed to application-specific or bespoke software. 

Contingency plans, maintenance and operating procedures Application macros, bespoke software and reports Security and access control methods... 

For the core LIMS, one must be careful not to be lulled into a false sense of security by the supplier s claim that the software is a standard product. What this usually means is that a set of software modules has been used in at least one or perhaps a few other LIMS installations. In this case, we must pose the question, "Is it really standard or in fact bespoke " The approach that should be taken to these "standard modules" is to determine if they are indeed standard (i.e., they are not revised to fit your LIMS application and have multiple applications for which references are available). If they are not standard, then confirm that the supplier has performed a Source Code Review or a suitable design review. If no review has been performed, the pharmaceutical manufacturer will need to make a value judgment on the risk this imposes (taking into account the results of the GLP assessment) and, if necessary, request that the supplier perform a Source Code Review as part of the project. 

The Source Code Review process will consist of assessing the agreed-on design against printouts of the produced software and data for any bespoke or configured part of the application in order to assess the application s GPP The aims of the Source Code Review are to... 

Standard software is composed of a set of functions that can be configured by logic switches defined in tables to fit individual business scenarios of a defined company. Indeed, a user may even decide to customize its specific application with bespoke programming to meet their particular needs. SAP s R/3 product is a standard software package consisting of several programs. 

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