During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.

The number of online pharmacies continues to increase exponentially and the global supply chain is at risk of infiltration by counterfeit ingredients. A more proactive approach is needed to ensure consumer safety.

The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.

The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.

Q: You have many years of experience in marketing and business development. What are the most significant changes you have observed in this time?

The adoption of computers into every aspect of the pharmaceutical industry has been enormous. Some estimates would put productivity and efficiency gains across the pharmaceutical industry at 2–3 times what they were previously. However, they are only just beginning to have an effect in the areas of training and document management, which have traditionally been managed by people and paper systems. With increasingly strict regulations and the growing complexity of processes and training requirements, there are even greater efficiency gains, as well as cost savings, to be achieved by adopting electronic document management systems (eDMS), learning management systems (LMS) and systems for the electronic signing of documents.

As a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.

Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.