Calvin Kim, senior director and head of IT Quality Systems & Validation at Samsung Biologics explores the fundamentals of data integrity and why a lack of critical strategic thinking could be affecting the success of implementing the technology.
Throughout every project, contract development and manufacturing organisations (CDMOs) will generate an abundance of data while relying on an array of computerised systems. These systems can assist CDMOs in their data management, security enhancement, human error reduction, and efficient execution of processes.
While advances in technology have enhanced and accelerated digitisation of processes, they have also highlighted the many complexities involved in safeguarding data integrity (DI) and maintaining regulatory compliance. Without fully understanding the intended use of the computerised systems utilised and the required mitigation of the associated risks, robust DI controls cannot be established.