PSC Software observed that the FDA and EMA have released a shared set of principles for the use of AI in drug development, covering areas like risk, validation, data governance, human oversight, and ongoing monitoring.
Public source
Publisher name
Public post
The FDA and EMA have released a shared set of principles for the use of AI in drug development. The guidance covers areas like risk, validation, data governance, human o…
Company
PSC Software
Making Compliance Less Complex, So You Can Focus on Innovation
- Industry
- Software Development
- Location
- Pomona, US
- Company size
- 11–50 employees
About PSC Software
PSC Software, provides inspection management and enterprise quality management software solutions that help life sciences and regulated industries bring products to market safely, efficiently, and in full compliance. Our applications meet the stringent requirements of highly regulated environments and support organizations in enhancing quality processes and reducing risk. We believe software should be both affordable and intuitive, offering our customers a clear competitive advantage through ease of use and robust functionality. PSC Software is a division of PSC Biotech Corporation. Together, we've proudly supported more than 1,000 clients across 50+ countries. To learn more about our solutions, visit https://pscsoftware.com/ For careers: https://careers.biotech.com/jobs
See moreLatest activity
Latest activity from PSC Software
2 signals
Discover more
Similar signals
Similar public activity from other companies.
Legal & Regulatory
PharmaLedger Association
PharmaLedger Association reports that FDA and EMA released joint AI governance principles.
Legal & Regulatory
NDA Group - an SSI Strategy Company
NDA Group - an SSI Strategy Company published draft guidelines from the European Commission clarifying how AI systems are classified as high-risk under the AI Act, including systems used in or constituting medical devices.
Legal & Regulatory
Veeva Systems
Veeva Systems reported that the FDA granted four AI-powered devices, including TEMPO: the Technology-Enabled Meaningful Patient Outcomes pilot, reach Medicare patients before any held full marketing authorization.
Legal & Regulatory
NSF - Life Sciences
NSF - Life Sciences announced that the EMA published Annex 22, the first AI-specific annex in the EU GMP Guide, detailing what a validated AI system looks like under GMP.
Legal & Regulatory
Mineral City AI