Complaints Remediation to Meet FDA Consent Decree Deadline Case study on Complaints Remediation to Meet FDA Consent Decree Deadline. Jim Macdonell - February 7, 2022 Case Studies Medical Device Manufacturing
Accelerating Compliance for Better Business Outcomes Case study on Accelerating Compliance for Better Business Outcomes. Erin Christy - February 5, 2022 Case Studies Medical Device Information Technology, Regulatory
Computer Software Assurance (CSA) Guidance Learn how the FDA's CSA framework modernizes software assurance in life sciences. Focus on risk-based testing, quality improvement, and patient safety. Sandy Hedberg - February 3, 2022 White Papers Biotech, Medical Device, Pharma Clinical, Information Technology, Manufacturing, Quality Assurance, Regulatory
How to Maximize Your GxP Use of the Public Cloud – Video Video on How to Maximize Your GxP Use of the Public Cloud. Stepheni Norton - February 3, 2022 Videos Biotech, CMO, CRO, Medical Device, Pharma Information Technology, Regulatory
FAQ: CSV, CSA, and Why the Paradigm Shift This FAQ curates many questions from our customers and attendees to our various webinars with the FDA on the CSA Guidance. Sandy Hedberg - February 2, 2022 Blogs Biotech, CMO, CRO, Medical Device, Pharma Regulatory
Top Cloud Insights for Life Sciences Your starting point in finding answers to your cloud questions, including regulatory compliance, audit and assessment, and validation. Various Authors - February 2, 2022 Blogs Biotech, CMO, CRO, Medical Device, Pharma Information Technology
