Pharma 4.0 Focus Data Integrity by Design Training Webinar: Newer Approaches and Technologies to Cost Effective 21 CFR Part 11 Compliance

Market opportunities arise from the growing need for modernization and compliance assurance in FDA-regulated industries focusing on data integrity. Emphasizing cloud computing, automation, and mobile ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Data Integrity Governance Webinar: Integrated Data Process Mapping & CSV Strategies to Strengthen Data Integrity, FDA 21 CFR Part 11/820 Compliance, and Risk Governance

The market opportunities lie in leveraging data process mapping to enhance data integrity and regulatory compliance, particularly aligning with FDA standards. There's potential in addressing gaps, ...
FiercePharma

Worried About Computer Software Assurance? Relax, You're Probably Already Doing It

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Yahoo Finance

2 Day Virtual Computer System Validation (CSV) Training Course: COTS, SaaS, IaaS, and PaaS Models with Best Practices for Validation, 21 CFR Part 11, and Data Integrity (Nov ...

We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, ...