Pharmaceutical expertise
Why pharmaceuticals?
Our specialist expertise
With roots in the pharmaceuticals industry and many years of SAP project management experience, we are the sector experts for SAP in the regulated environment. Thanks to our knowledge of current provisions and regulations, the complex creation of documented verification regarding correct and predefined system functionality never exceeds time and budgetary constraints.
Our linking role between implementation partners and customers
The technical know-how of SAP partners is rarely matched with knowledge of the pharmaceuticals sector. On the other hand, pharmaceutical companies may specialise in the sector, but rarely have experience of large-scale software implementation. This is where our expertise and specialist knowledge come in: we have built up a comprehensive understanding not only of SAP technology, but also the pharmaceuticals sector – including the legal framework. As a result, we are able to base realistic project planning on the appropriate method in every case.
Our knowledge of local and international legal frameworks
In the pharmaceuticals industry, it is particularly important to apply and observe the prevailing legislative regulations. In the European Union, compliance with the EC-GMP Guide Annex 11 is required while companies supplying the US market are focused on the Code of Federal Regulations compliance; other applicable guidelines include GAMP and PIC/S. However, given our activities in the USAand our increasing involvement in Asia and Australia, we must also ensure our methods and working practices accord with local conditions in these areas – and we are consistently meeting these prerequisites.
Our understanding of processes
The implementation of an ERP system calls for the systematic checking of special functional requirements such as batch where-used lists, the implications of 21 CFR Part 11 and the authorisation situation particular to the pharmaceuticals industry. The methods we apply, which include structured procedures and specific guidelines, guarantee GMP-compliant production for customers.
Our validation activities are fully integrated into the project life cycle
For any competitive pharmaceuticals company, now and in the future, it is critical that projects are realised within fixed timeframes and budgetary constraints. Under our method, validation – a central element of every project – is carried out by the project team within the scope of their normal activities. This enables us to plan and monitor projects and ensure they are resistant to financial pressures.
