Life sciences companies often operate globally whether
conducting clinical trials across several countries, or
manufacturing and distributing products in multiple regions.
Even organizations that start with limited geographic
footprint may eventually depend on the global life sciences
cosystem to enter new markets, externalize operations,
make acquisitions.

Maintaining quality oversight and end-to-end control of the
value chain, while addressing local market requirements is
xtremely difficult. Organizations often use multiple systems
and processes to manage these functions. Creating
information siloes — fragmented processes impede growth,
gility, and more importantly, adversely affect quality. Modern
technology facilitates alignment and sharing of information
across regions, and enables more effective governance for
harmonized processes and content.

Requiring significant investment and stakeholder buy-in to
achieve success, there are advantages to making this
transformation now, versus later. Regulatory agencies’
approach to quality is evolving, and only demonstrating a
ate of control and compliance during inspections will no
longer be sufficient. Operational alignment also improves
collaboration and enables global visibility on quality for
faster decision-making. Companies with a harmonized
and global approach to improve quality, partnership success,
and more importantly can take advantage of emerging trends.