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This question can be answered after looking at the software level definitions in the GAMP guidelines. They define several levels of software which include three that are appropriate for end users. Each one has it pluses and minuses so it is useful to understand the differences.

    1. The first of these is “Standard Software Packages” which are commercial off-the-shelf software (COTS) which are configurable. This is used as-is and requires the minimum amount of IT support and maintenance.


    1. The second is “Configurable Software Packages” which allow users to configure predetermined software modules and develop new software modules. Several manufacturing execution systems such as Honeywell POMs and Werum fit this category.


  1. The third is Custom (Bespoke) Systems which are unique applications developed to meet the needs of a specific user group or company. Often these are home-grown systems that are great when first developed, but over time become archaic as newer technology emerges.

Over the past 30 years I have had responsibilities for laboratory and manufacturing automation in Pharmaceutical R&D. I have seen all types of software installed or configured or developed from scratch. From those experiences, I’ve formed my own conclusions about what makes the most sense for the end user. In almost all cases, the end user wants something simple and reliable. When they get comfortable with a system, they don’t want it changed. In my opinion, the most practical approach is a commercial off-the-shelf software that does the majority of what the end users need.

After having built two home-grown (Bespoke) laboratory information management systems from scratch, I realized that this was not an optimum way to go. We could build the functionality that end users said they wanted in the beginning. Later it became clear that the end user did not know what they needed until the system could not perform functions that they needed. Most of the time people know what they want, but rarely do they know what they need until they can’t get it. It turned out that building from scratch to meet immediate end user requirements was not a sustainable approach.

The next two systems I managed were Configurable Software Packages. One was Labware and the other was Beckman CALS. These systems seemed great at the beginning because they had all of the needed functionality built in, but could be configured to meet any kind of specific operations. That flexibility, however, became its Achilles Heel. Because they could be highly customized, it took a team of specialists to understand and configure the software. The end user was often confused because the software may have been the same across the whole company, but it look entirely different from one department to another. In one case where we had a global operation with the same software in 12 different plants servicing 15,000 users, the system in one plant could not transfer information to any of the other plants. It was a case of too much of a good thing that turned into a problem.

When we started the development of the InstantGMP™ electronic batch records, we designed it from the beginning as a user-friendly system that would be easy to learn and use. It order to meet that goal, we engaged a team of manufacturing specialists to write out the work flows for the entire operation. Our intention was to coordinate all of the activities involved in good manufacturing practices into one application that would take care of compliance for the end user automatically. The end result is a commercial off-the-shelf manufacturing execution system with electronic batch records that makes cGMP manufacturing easy.

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