Why healthy pharma manufacturing needs full integration

Tony Brooks, Exel Computer Systems, looks at why pharmaceutical manufacturers need to get to grips with integrating their systems for improving business processes and overcoming data issues.

Like any manufacturer, pharmaceutical companies have to have their business processes in perfect health. Yet more than most other manufacturers, failure to do so is not just a matter of profitability and success, it can also be one of life and death, literally. Quality control of raw materials, recipes, specifications, workflow as well as the finished product is paramount, with exacting standards often applying to the receipt and storage of raw materials in addition to the storage and dispatch of finished goods. With all of these areas governed by some of the most stringent regulation and compliance standards in the world, it is no wonder that the demands made by pharmaceutical and medical companies on their manufacturing IT are amongst the most stringent.

The problems many pharmaceutical companies struggle with in terms of their manufacturing IT stem from using a variety of different non-connected or loosely connected IT systems. Data issues including duplication, variation, and version control are inherent with such an approach, especially where different departments may for example, be working off different versions of the same spreadsheet for critical areas such as specification or formulation documents. Moreover, using different systems for different areas within the business, for example stock control, production control, accounts, warehouse and dispatch can also lead to a lack of visibility across the company. By definition, these requirements are best met by a fully integrated manufacturing business solution with a central database.

Integration is the key
An example of this is Bioshell Teo., based in Co. Mayo. Bioshell provides sub-contract manufacturing services to larger healthcare firms, producing tablet and capsule vitamin and food supplement products to customer formulations. As a growing company, by 2001 it had become clear that a single integrated software solution was warranted, to cater for expansion and provide a platform for growth. Up until that point, the company had relied on an Access-based system to manage stock, while an Excel-based spreadsheet took care of production. The principal difficulty was a lack of integration between the two systems and was causing severe problems including an inability to distinguish between available stock to hand versus on-order; little or no control over formulations; and a duplication of effort which was becoming unacceptably time consuming.

Following a rigorous selection procedure, Bioshell chose EFACS E/8, supplied by MXI Software, as the system of choice owing to its flexibility, and ease of use. Two years down the line, Bioshell now have a state-of-the-art, fully integrated, manufacturing and financial system. EFACS is used to control production, stocks, purchasing, sales, formulations and all of the standard financial functions required. Its in-built links to Microsoft Office allow for quick reporting in a familiar environment within Excel. Should the system be browser based and platform independent, as is the case with EFACS, integration with specialist legacy systems such as Laboratory Information Management Systems (LIMS) becomes much simpler.

Other important benefits follow
Other benefits of a fully integrated system include the potential for incorporating workflow control procedures stemming from powerful document management and permissions functionality. Version control of key documents such as specification and formulation documents provides the most effective way to minimise and even completely avoid any duplications or variations, thereby ensuring complete confidence at each step of the production process. This can be reinforced by a system which dynamically requires a positive confirmation at each process step before the system allows production to continue. In addition to providing an effective safeguard against error, the automatic auditing which is generated allows any mistakes to be quickly identified by absolute precision, a key requirement for traceability compliance.

A less obvious, but very important requirement of a successful Pharma manufacturing IT system is its need to be customisable to the specific needs of a pharma company. The culture within a pharmaceutical company is often much more scientific than a traditional manufacturing environment and so the terms used often reflect this. A system which can be configured and customized to minimise the disruption to those using it provides a huge advantage in terms of achieving a successful implementation, with maximum buy-in from the end users.  Again, this was the experience of Bioshell, which found that unique to EFACS, and seen as a distinct advantage, was the facility to localise the standard EFACS terminology to that of Bioshells own environment. For example, the use of the term Bill of Materials has been replaced with Formulation.

Platform for growth
Using a system that genuinely caters for the specific challenges of the pharmaceutical and healthcare industries provides for much more than avoiding the significant risks of not doing so. It can prove to be a firm foundation on which to increasingly and successfully compete in a challenging business climate. With a leading-edge, proven ERP system in place, Bioshell is now in the position of seeking approval from the relevant regulatory bodies. As further testimony to the potency and strength of EFACS, Bioshell has plans to develop its own patented products. According to Reiner Eschwey, Director at Bioshell, With EFACS now in place we can start the ball rolling to look for validation by the FDA [US Food and Drug Administration]. This will greatly enhance our chances with larger contracts and will allow us to continue to grow into the future.

Tony Brookes is sales and marketing manager for Exel Computer Systems. The company specialises in the provision of integrated business systems, serving an increasingly diverse customer base, which includes small, medium and large size companies. With hundreds of successful implementations, and thousands of users, EFACS E/8 is a proven product helping to run some of the world's most well known companies.