Who’s responsible for what in the validation process?
Meeting validation requirements ensures that life sciences organizations achieve regulatory compliance and helps them to maintain product quality and safety. Responsibilities are distributed among various internal teams and third-party vendors, but ultimately, the organization is held accountable during audits and inspections.
As more and more life sciences organizations adopt software as a service (SaaS) and cloud technologies, they need to know how to leverage vendor activities like development, testing, documentation, release management, and support. Furthermore, the FDA’s Computer Software Assurance guidelines encourage the use of leveraging vendor activities and it can minimize your validation burden.
Download Validation Requirements and Responsibilities to learn more about validation and qualification and:
- Discover solutions for data integrity challenges.
- Explore options for offloading some of your validation burdens.
- Find out what artifacts vendors typically share with customers and what you can leverage.
- Learn how to bridge any gaps in validation responsibilities.
Contributors to this white paper:
- David Blewitt, VP of Cloud Compliance
- Sandy Hedberg, Director of Quality Assurance and Regulatory Affairs
- Hovsep Kirikian, VP of Strategy and Operations
- Jim Macdonell, VP of Eastern Region, Medical Device Solutions
- John Petrakis, VP of Cloud Assurance
