The benefits of using a lifecycle approach to the implementation of COTS software in pharmaceutical manufacturing plants

Modular Dispensary Management Software

Manufacturers of pharmaceuticals are increasingly implementing commercial off-the-shelf (COTS) software instead of commissioning bespoke packages. The reason for this is that the COTS approach offers a number of advantages, such as reduced project risk, shorter timescales, lower cost and better prospects for long-term support. However, if a COTS software implementation is to be successful, it is important that a rigorous approach is taken to project management, but without expending excessive resources on areas that do not warrant it. Indeed, this is one of the messages in GAMP5, published earlier in 2008, which supports a risk-based approach to qualification.

CI Systems used to produce bespoke Dispensary Management Systems but around six years ago developed a modular, configurable DMS package that is easier, quicker and more cost-effective to implement. The only aspects of the system that tend to be customer-specific are the interface with the ERP (enterprise resource management) system (e.g. SAP, JD Edwards, MFG PRO) - if required - and the design of the barcoded labels for the containers of dispensed material.

In common with the recommendations in GAMP5, Ci-DMS benefits from an iterative software development method. This contrasts with the traditional 'waterfall' method (of distinct specify, design, code and test phases), with any problem requiring the specification to be revisited and a large amount of effort having to be expended on resolving the knock-on effects of a change.

Having successfully implemented more than ten modular Ci-DMS packages, CIS developed a lifecycle project management scheme and set of document templates that enable the implementation process to be streamlined still further. Over the last two years this has proven to be highly beneficial, as it enables CIS to work with customers extremely effectively, with customers having to provide minimal resources and the disruption to production kept as low as possible. Three systems have already been installed using this lifecycle methodology, and another five are currently in progress.

The CIS Project Lifecycle comprises four phases: Project Initiation, Configuration, Validation and Qualification. With the aid of a detailed and co-ordinated implementation plan, which is monitored throughout the lifecycle, projects can be completed smoothly, on time and within budget.

The project plan is closely monitored throughout the project lifecycle but, to minimise costs and customer workload, the number of on-site project meetings is restricted. Project review teleconferences are used to provide the right level of communication in the most efficient manner. Activities such as software installation, shakedown testing and software updates (prior to the system going live) can be performed over a VPN (Virtual Private Network); subsequent software updates can also be obtained via CIS's FTP (File Transfer Protocol) site.

If a customer is unable to commit sufficient project resources, CIS offers an enhanced project management service, whereby CIS effectively takes full responsibility for implementing the system, managing both the CIS and customer activities.

For more information about CI Systems' Ci-DMS Dispensary Management System,
call 01722 424100 or email sales@cielec.com

www.cidms.co.uk

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