Data Integrity and Computer Systems Validation Challenges for Start-Ups Heading for Regulatory Licensing

Synopsis

The presentation will explore the DI and CSV challenges faced for new start-up companies progressing towards regulatory licence. Recent years have seen a vast increase in the volume of new organisations starting up especially in the areas of Cell Gene Therapy, mRNA and DNA technology.

While these organisations may be leading edge with regards to the science and technology, of the aspect of DI and CSV compliance is seen as a secondary or even lower priority – until the aspect of submission for licence inspection occurs.

In addition to the pure DI and CSV journey there are a number of additional areas that need attention during this journey, the presentation will draw on the experience gained in the last 2-3 years helping a number of clients on this journey to successful licence.