Digital Transformation In Regulatory: Achieving Excellence Virtually

The COVID-19 pandemic demanded significant pivots in how life sciences professionals and regulators carried out their responsibilities. Remote working was imposed in many regions to minimize the spread of disease, so technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to good manufacturing practices (GMP).

This was a substantial change, as a recent survey conducted by Cambrex showed that before the onset of the pandemic 57% of respondents had never undertaken a virtual inspection (see Figure 1).

Such rapid digital adoption was a direct reaction to continue operations and would undoubtedly have taken longer to become widely accepted without the catalyst of the pandemic. Nonetheless, this implementation has largely been successful, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) stating it sees “added value in retaining these practices beyond the pandemic.”¹ Additionally, the FDA has indicated support of virtual GMP inspections, announcing the development of guidance on the topic.² As the industry looks forward, key decision-makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.