PRESS RELEASE 31 May 2006

MODULAR SOFTWARE ARCHITECTURE REDUCES TIME NEEDED TO IMPLEMENT DISPENSARY MANAGEMENT SYSTEMS

By William Eaden, CI Systems Ltd

Pharmaceutical manufacturers wanting to implement a dispensary management system (DMS) will, inevitably, all want something different. However developing a system unique to each customer is unfeasibly expensive and time-consuming, so suppliers today have COTS (commercial off-the-shelf) packages that should, in theory, be suitable for the majority of applications.

However, no system can be expected to 'work straight out of the box', as there are always other systems with which the DMS must interface. And the diversity of manufacturing execution systems, enterprise resource planning and recipe management systems that are currently available means that it would be virtually impossible for a single DMS vendor to have pre-prepared interfaces available to suit every conceivable scenario.

Pharmaceutical manufacturers therefore expect that an amount of configuration will be required as part of a DMS project but no longer expect any software modifications. Taking the COTS package and turning it into a system that suits a particular requirement is a matter of configuring the numerous settings. Some of these will be visible at the 'front end', such as the choice of names and the layout of printed labels, while others will be behind-the-scenes elements that relate to the way the actual process hardware performs its functions.

Identifying the Raw Materials

Silo dosing with Ci-DMS

Software for use within pharmaceutical manufacturing must meet stringent requirements laid down by the FDA (USA Food and Drugs Administration), EU and national regulatory bodies. Documented procedures must be followed rigorously when specifying, writing and testing software, which means that the overall process can take a remarkably long time.

In the past a DMS package would have been constructed from thousands of lines of code compiled into a number of distinct executable modules - one per functional area (e.g. supervisory, manual dispensing and bulk dispensing). This meant that each module consisted of a substantial piece of software that was difficult and time-consuming to maintain.

State-of-the-art DMS architecture consists of multiple object-orientated modules compiled together into logical dependent components (i.e. EXE’s or DLL’s), each of which is validated in its own right. The key benefits of object oriented design are: robustness, maintainability and reusability, all essential requirements of the pharmaceutical industry. Making a change to the overall DMS package therefore means that only specific modules have to be altered, which makes the process far quicker and simpler. If an entirely new module is required it is self contained and, as a result, the development time is substantially reduced.

For the customer, the net result is a reduction in the time to IQ/OQ (installation qualification and operational qualification) for software updates, which makes them practical whereas in the past customers would refrain from installing them. This means that customers can easily upgrade their existing system to take advantage of new functionality or to support technical changes (e.g. new databases, operating systems or hardware) whereas in the past they would have had to purchase a new DMS system.

Another benefit delivered by the high-granularity approach is that it is easier to satisfy systems for customers that operate subtle variants of the same process equipment within the one facility. For example, the plant capacity may have been increased over time by adding new equipment, which may operate slightly differently from the original items due to advances in technology. A configurable DMS will have been designed to support a wide range of equipment but yet keep the user interface the same.

Continuing along the same logical path, customers that have multiple plants often desire a common user interface for all process equipment of the same type. This can be achieved easily using a modular DMS package. There may be historical reasons for the authorisation procedures to vary from one plant to the next and this can also be accommodated with ease when a modular package is being implemented.

This greater versatility does not mean that a customer should readily make changes to the DMS configuration after it has been implemented and validated, as the overall system will have been validated in line with GAMP (good automated manufacturing practice). Nevertheless, so long as the user has taken time to specify the required system accurately in the first place, it should prove to be fit for purpose and not need any re-configuration.

High-modularity architecture such as Ci-DMS has proved to be effective and reliable and pharmaceutical manufacturers find that such systems deliver the advantages of a custom system but without the risk, time and cost associated with custom-written applications.

For more information about CI's Dispensary Management System, please telephone
+44 (0) 1722 424100 or e-mail sales@cielec.com