Newsletter | August 30, 2021

08.30.21 -- Current Data Privacy Regulations Impacting The Life Sciences Industry

Current Data Privacy Regulations Impacting The Life Sciences Industry

The General Data Protection Regulation (GDPR) is a significant advancement in consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, South Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Learn how to mitigate risk and keep on the right side of regulators.

Best Practices For Effective Quality Documentation Processes In Drug Manufacturing

There is always a balance between speed and compliance, while others struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both business stakeholders and auditors is a tall order. This article chronicles the trends that quality and compliance teams adopt to keep pace with the speed of discovery.

Best Practices For 21 CFR Part 11 And GxP Validation For Electronic Records

Drug development has dramatically changed over the past ten years. A practice once dominated by pen and paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This article chronicles recent technological trends, specific challenges these trends pose for quality and computer system validation (CSV) teams, and best practices for tackling resulting compliance issues.

Why Life Sciences Needs The Science Of Security
Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.
3 Ways To Mitigate Data Manipulation Risk In Drug Development

A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

Top 5 Risks That Can Compromise Your Life Sciences Data
Keeping clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, here is a list of five common ways that trial data put us in jeopardy and approaches you can take to avoid these risks.