In the life sciences industry, a comprehensive validation program that includes compliance with FDA 21 CFR Part 11 is essential. Yet, most organizations’ efforts to meet these expectations remain based on validation strategies that were developed in the early 2000s—when paper documentation, protracted “waterfall” release cycles, and fairly static data sets were the norm.
Now, the complexity of compliance is greatly increased as more and more life science companies adopt Agile to accelerate innovation in today’s ever-evolving digital world.
Read this paper to learn about:
- The industry trends forcing companies to rethink their approach to compliance challenges
- Steps you can take to make sure your computer systems validation program is correctly planned, developed, managed, and controlled across Agile testing efforts
- How the proven best practices for meeting FDA expectations in “waterfall” software development processes can be adapted to accommodate teams adopting a more Agile approach