This paper focuses on an industry shift to a risk based approach to Computer Systems Validation, illustrating the industries appetite for change in a manufacturing and lab environment. This paper also focuses on how accurately testing critical systems, reduces unnecessary documentation time, increases value delivery time and reduces cost of deployment.

In this whitepaper, we discuss how cyber – resiliency programs can help manufacturing companies to respond to and recover from cyber attacks, while minimising the impact on the core business processes. We also look at how to avoid operational disruption and maintain the integrity of critical systems and data.

The biopharma industry has experienced rapid expansion over the last three decades. Total annual revenue has increased from $4.4 billion in 1990 to $275 billion in 2018 and biopharmaceuticals now make up more than 25 percent of the total pharmaceutical market.

This whitepaper will enable you to understand Industry 4.0 and its relevance in Life Science Manufacturing. Use proven solutions and approaches to create never before seen (or possible) quality and reliability standards, and discover the technologies and approaches that will facilitate such change.

This white paper sets out a roadmap for the successful implementation of a serialization programme applicable to pharmaceutical companies of any size and complexity. It is based on practical experience of implementing serialization for some of the world’s largest companies.