Conformia’s service oriented architecture (SOA), which has been fully validated by IBM, enables applications running on the latter’s product stack platform to exchange process development and performance data, thereby allowing the constant monitoring of production efficiency.
Conformia also believes that the full integration of the SOA platform into IBM’s platform offers pharmaceuticals and biotechnology producers a complete “off-the-shelf” data management solution that can be applied to existing manufacturing setups.
Anjali Kataria, Conformia’s chief marketing officer, said that the product combines the firm’s knowledge and expertise in the drug sector with IBM’s strength in pharmaceutical industry business transformation to help manufacturers adopt a quality by design (QbD) approach to development that is compliant with the International Conference on Harmonisation’s (ICH) quality vision.
Kataria added that: “Our work with IBM both validates and strengthens our continued dedication to making product development more efficient so scientific leadership can do more with the same resources.”
These opinions were echoed by IBM’s general manager of global healthcare and lifesciences, Dan Pelino, who explained that: “As one of the most heavily regulated and complex industries, the pharmaceutical sector presents a myriad of unique challenges to organisations during their product development lifecycles.”
He added that the new platform was designed to meet the drug industry’s increasing demand for “an integrated data and information environment, resulting in more effective knowledge-management programs.”
Increasing regulatory demands for safe and effective pharmaceutical products means that manufacturers are required to amass vast amounts of data at all stages of the product development cycle.
Additionally, within the wider drug industry, demand for ICH-compliant design solutions has increased considerably in the last few years. A recent survey by US market research group AMR revealed that around 75 per cent of drug companies either have or are planning to have ICH QbD programs in place in the next six months.