Download to continue reading
There is a lot of discussion surrounding what is to come from the FDA and how it will impact regulated businesses.
Life sciences companies are adopting native cloud-based technologies and are starting to leverage these digital technologies for strategic advantage. The efficiency derived from cloud computing is more than just financial. A multi-tenant cloud platform provides greater elasticity, scalability, security, and performance as compared to a single-tenant system.
Further, the cloud is driving entirely new business models to enable rapid growth and global collaboration while maintaining quality and compliance standards. The journey to the cloud is a necessity to survive and thrive in today’s hyper-competitive business landscape.
In this white paper, we address why enterprises must prioritize their digital transformation and how quality and compliance need to be at the forefront of that transformation to create a strategic advantage.
In an effort to harmonize with international standards, the FDA Center for Devices and Radiological Health (CDRH) plans to release a new draft guidance, “Computer Software Assurance for Manufacturing, Operations, and Quality System Software,” that aligns with the current quality systems regulation ISO 13485.
As the FDA begins to change focus from compliance to quality, encouraging the use of automation and new technologies, we anticipate the new draft guidance will define a modernized approach to CSV. As the industry eagerly awaits the guidance release, there is a lot of discussion surrounding what is to come from the FDA and how it will impact regulated businesses.