In this presentation, we'll explore the creation of FDA-compliant approval workflows within the Microsoft Power Platform, with a specific focus on meeting the stringent requirements of 21 CFR Part 11. Our journey will encompass:

1. Developing a streamlined approval workflow in Power Automate
2. Constructing a custom approval component using the Power Platform Component Framework
3. Deploying and demonstrating this component in action

21 CFR Part 11 is a crucial FDA regulation governing electronic records and electronic signatures in the life sciences and healthcare industries. It ensures the authenticity, integrity, and confidentiality of electronic records, making it indispensable for organizations handling sensitive medical data or developing pharmaceutical products.
A key challenge in achieving 21 CFR Part 11 compliance within the Power Platform environment is the authentication process. While Power Platform typically utilizes silent Single Sign-On (SSO), compliant workflows demand explicit user authentication, including username, password, and Multi-Factor Authentication (MFA).
To address this, we've developed an innovative custom component that initiates the Microsoft login page, enabling full user authentication with MFA without disrupting current login sessions. This solution bridges the gap between Power Platform's standard authentication and the rigorous requirements of 21 CFR Part 11.
By implementing these FDA-compliant workflows, organizations can ensure regulatory adherence, mitigate risks, and maintain the highest standards of data integrity and security in their digital processes.

Some key takeaways include:

1. The solution ensures compliance with 21 CFR Part 11 while leveraging existing Microsoft investments, providing a cost-effective approach to meeting regulatory requirements.

2. It offers enhanced data integrity and security measures, crucial for organizations handling sensitive medical or pharmaceutical data.

3. The streamlined operations and reduced human error can lead to faster time-to-market for regulated products, providing a significant competitive advantage.

Required : Azure AD (Entra access), Power Platform, VSCode, MSBuild, Power Platform CLI components.