21CFR Part11 Cloud based GxP Compliance Webinar скачать в хорошем качестве

21CFR Part11 Cloud based GxP Compliance Webinar

The term GxP is a general abbreviation for good practice guidelines and regulations in the life sciences industry, including good clinical, laboratory, manufacturing, and other practices. Computerized systems that use GxP processes require validation of adherence to GxP requirements and are considered qualified when the system can demonstrate its ability to fulfill them. Deploying a cloud-based GxP application needs a comprehensive strategy for a successful independent third-party audit. These applications should determine the GxP requirements that apply to the computerized system based on its intended use and follow internal procedures governing qualification and/or validation processes to demonstrate that the GxP requirements are met. In this webinar, we will share our experience as an independent third-party auditor, insight, and implementation experience that will helps organizations and individuals to formulate a strategy for meeting regulation enforced by the FDA 21 CFR Part 11.