IBM has launched a new software package designed to make it easier for small and medium-sized pharmaceutical and biotecnology companies to cope with the compliance requirements of the US Food and Drug Administration.
The system, called the IBM BioPharmaceutical Solution, is a fixed-price package based on the widely used SAP business applications platform and can help companies comply with the FDA's 21 CFR Part 11 requirements on electronic record keeping.
"Small and mid-sized pharmaceutical and biotech companies are often the source of innovative treatment techniques and need to move them to market quickly to help patients. However, these companies must comply with rigorous regulatory mandates put in place to protect consumers," said IBM in a statement.
In a series of deals unveiled recently, Germany's SAP, which is Europe's largest software company, has been positioning itself as a supplier of IT systems for small- and mid-sized businesses, not just corporate giants.
SAP is the leading player in the enterprise resource planning (ERP) software market, with sales topping $7 billion in 2003, according to AMR Research. Most big pharmaceutical companies have developed their own, bespoke SAP-based systems, but smaller companies have found it difficult to fund this type of effort. BioPharmaceutical Solution is intended to put SAP within the reach of a much broader spectrum of companies.