Werum supports global MES rollout strategies

Werum Software and Systems, one of the leading and most experienced suppliers of MES for the pharmaceutical industry, has put a special focus on optimising the procedures in MES projects

In general, implementations of full-scope Manufacturing Execution Systems (MES) in pharmaceutical production facilities are comprehensive and challenging projects - both with regard to IT requirements and organisational demands.

Pharmaceutical companies as well as MES suppliers will certainly agree with this assessment - in particular, if the MES project includes several plants.

For many years, Werum Software and Systems, one of the leading and most experienced suppliers of MES for the pharmaceutical industry, has put a special focus on optimising the procedures in MES projects.

This is logical, as shorter project runtimes and lower MES implementation costs are beneficial to the customer and ultimately to Werum.

Within the scope of a supplier selection process, customers assess the concrete benefits of an MES and consider the effectiveness of project workflows.

Consequently, the lower the project risks for the customer the better the chances of the supplier winning the contract for carrying out the MES project.

Based on work done with customers, such as Novartis, for a few years already, it has been the Werum strategy to apply a rollout approach for multi-site MES installations, a procedure that significantly reduces project duration and costs.

In general, such a global rollout strategy offers major advantages to pharmaceutical enterprises.

For a successful rollout scheme, it is essential that the pharmaceutical enterprise fully supports the use of MES to manage their production processes and plans to install MES systems in strategic sites in a structured way.

This is proven by Novartis, for example.

In their pilot project, the standardised business processes, which generally should be applicable to all scheduled installations, are defined and verified.

This way, it is possible to reduce considerably the costs of subsequent projects.

Werum supports this approach by means of an adequate project organisation characterised by core project teams that cooperate with the customer's local project managers in a global partner relationship.

The particular features of the MES product PAS-X further boost the advantages of the described approach.

The standard functions of PAS-X are based on best practice business models developed along with the user community.

Moreover, this MES software is highly configurable while offering the flexibility necessary for modeling specific processes to be implemented in individual production facilities.

A Case Study: Novartis.

The Swiss-based pharmaceutical company Novartis is one of the Werum customers that has decided to follow a global rollout strategy.

Novartis pursues a global rollout scheme and intends to install a standard MES by Werum within the next years in their production sites located all over the world.

Besides the benefits provided by operating the various sites with an MES, it is the Novartis goal to reduce implementation times and costs by applying a rollout principle.

By mid-2004, Werum successfully concluded the installation of its MES Pas-X Pharma at the company's production plants in New York, USA, and Barcelona, Spain.

As expected by Novartis, the practical advantages of the rollout strategy have become clearly visible after the second project.

In particular the transfer of technical know-how, knowledge and expertise gained during the first implementation was of great benefit to the second site.

The second project in Barcelona benefited from the experience acquired in the first MES project carried out in the New York plant, minimising the project risk.

Additionally, Novartis employees in the US worked closely with their colleagues in Spain to ensure a smooth implementation.

These collaborative activities led to a substantial overall gain of time.

For Werum, the duration of the second project in Spain totalled just nine months including all phases from specification through installation to validation.

Compared to the first implementation in New York, the duration of system set-up and associated project costs for the installation in Barcelona were reduced.

Due to Werum meeting the Novartis expectations on the project implementation, more PAS-X implementations at other production sites are planned.

Based on the Novartis experience, multi-site MES implementations result in time reductions for individual tasks, which Werum estimates as follows.

* Functional Specification 75%.

* Design Specification 75%.

* Design/Implementation 75%.

* Parameterisation 50%.

* Testing 50%.

* Site Acceptance Test 50%.

* Documentation 75%.

No time-related advantages can usually be expected for start-up and commissioning or translation work.

Also the expenditures for user training amount to approximately the same as follow-up projects.

On the whole, the rollout approach minimises project risks and decreases failure ratios.

Based on experience gained by working with Novartis, Werum now advises customers to establish an enterprise-wide competence team for preparing and carrying out the various MES implementations.

Such competence teams certainly play a decisive role for the success of the overall project.

Pharmaceutical enterprises with production facilities at different locations will benefit from the replacement of specific solutions in particular plants by standardised MES software.

The savings potential is substantial both while the system is set up and when it is operative.

An example in this context are lower expenses for support and maintenance, which reduce the total costs of ownership.

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