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Regulatory compliance

The challenges of compliance and validation in pharma and life sciences are becoming increasingly complex and demanding. As a pharmaceutical manufacturers or distributor, you must achieve and maintain compliance with GxP regulations and guidelines from international agencies and organizations (EMA, FDA, WHO, ICH, etc.).

Security

Along with the increased complexity of processes and systems, security risks are becoming more prevalent. As a result, your  ERP must support optimal security, full traceability and electronic signature capabilities in compliance with international standards (e.g. 21 CFR Part 11 from the US Food and Drug Administration).

Effective collaboration

The need for effective and efficient cooperation, communication and connection beyond company and country borders is increasing in pharma & life sciences. This requires flexible and easy-to-use collaboration tools to exchange information and data with third parties.

Time to market

Combining scientific innovation with patient-centric business needs means that time to market – from front end to clinical trials – is often under pressure. There is an increasing demand to leverage agile methodologies and technologies to enhance efficiency, accelerate outcomes and proactively respond to ever-changing market & competitor conditions.