The Company

McNeil is a Johnson & Johnson multinational company. Based in High Wycombe, the company concentrates on the development and marketing of over-the-counter pharmaceutical products that previously were available only on prescription. Products include such well-known brands as Imodium and Ibuprofen. 

McNeil is geographically spread across Europe, with staff in UK, Ireland, France, Germany, Spain and Italy. Research and development of new products and extension of market life for existing products is carried out in Bordeaux. The company is marketing led, with each ?product franchise? having its own dedicated marketing team.

The issue

The documentation and regulatory requirements for pharmaceutical products are arduous and extensive. These are made more difficult for McNeil due to its pan European structure. For this reason, the Company has a Regulatory Affairs team operating from High Wycombe with managers in each of the countries. Their role is to cover all issues relating to taking products to market across Europe.

Cheryl Hall, Head of Regulatory Affairs at McNeil, recalls that one of the main problems she had when she joined the company was making sure that everyone involved with a particular product, had access to and was reading the same version of documentation. She saw the documentation issue as a potential hazard and hindrance in taking new products to market. ?We needed to make sure that everyone was reading and singing from the same hymn sheet? she said.

?I saw this as an ideal application for an Intranet. But, prior to joining McNeil, I had seen a similar problem with another large pharmaceutical company. That company had invested some £12 million in a documentation control system and that needed a raft of people to run it. You had to have PhD to use it. I wasn?t about to fall into that trap?, she comments.

Finding the solution

The outline requirement for an intranet documentation management system was prepared, with three key factors. The solution had to be managed in Bordeaux; it had to be simple to operate with minimal staff; it should be realistically priced. Five Internet solution suppliers were asked to submit recommendations. According to Cheryl Hall, all but one of the companies failed to fully comprehend the problem and appeared more interested in showing off their technical and design skills. ? Only Edeptive seemed to understand the management and organisational issues, and came up with a viable proposition?, she adds.

The Edeptive solution was based on its content management system, edeptive?. One of the benefits of using edeptive? is the ease of tailoring it to meet specific customer requirements. Its design allows application modules to be designed and added to its core functions. In the case of McNeil, a complete document management and control system was designed and implemented within 12 months from the decision to go ahead. And, whilst being easy to use, it provided all levels of management with operational status and statistical information never before available.

Implementation & Training

The implementation and training process included training all regulatory staff in each country. This consisted of a one-day course covering site content management, filling in templates, plus a ?sand-pit? training site for practical experience. Once trained, project mangers were given content templates, which they then populated with product details. The new system was launched to McNeil staff across Europe in 2003. ?It?s not until you get into the post launch nitty-gritty that operational issues rear their ugly heads?, comments Hall, ?but our system had to fit us like a glove and so there were fine tuning modifications and adjustments that needed to be made. Where they involved Edeptive, they were fixed in just a few hours.?

The benefits

Before the edeptive? solution, it was impossible to analyse historical feedback. There just wasn?t any historical data. Now, management is able to review the effectiveness of each stage of product development, how many changes were made, by whom, and what were the nature of the hold-ups. Now, project status is always known.

One of the latest facilities to be added to the system is electronic ?sign-off? of documentation. This incorporates an email sign-off reminder feature and is seen to be yet another signifi cant time saving facility. ?What we have now is a simple to use yet invaluable management tool. Cheryl Hall explains. ?edeptive? has given us all that we asked for and more.

The ability to :

? learn from past product projects
? estimate time to market for new products
? provide transparent project management
? a European-wide common level of understanding.

In essence, we now have the benefi t of far more knowledge about our product development process. This in turn is leading to better decisions and ultimately reduced time to market for new products?.

Future plans include using the new system for managing on-going change control for launched products.

The Internet Applications Framework

edeptive? Internet Applications Framework (IAF) supports the development and deployment of strategic and tactical applications on the web and other platforms. At Edeptive we use edeptive? IAF to design and develop Internet applications for our customers and partners.

IAF technology enables our customers to rapidly and cost effectively deploy functionally rich applications on the Internet, Intranet, Extranet (web) and other platforms such as mobile WAP, Personal Digital Assistant (PDA) and Digital Television (DTV).

edeptive? IAF uses its own powerful content management system (CMS) as its engine thereby giving users a single system with which to manage and control the targeted publication of content from multiple diverse applications.

Unlike most other CMS vendors, Edeptive believe that it is essential for any CMS to be able to support the management of many differing types of content such as news, events, job vacancies, product catalogue information etc. Edeptive?s many years of experience has proved that each of these content types has distinct characteristics - with some requiring signifi cant applications logic.

edeptive? has extended the concept of content management by the development of Application Modules. Application Modules handle special types of content in a structured way within a single unifi ed framework - using exactly the same system and controls that are used to manage generic content.

The unique architecture of edeptive? enables the rapid development of additional modules that may be required to meet your specific requirements.