Validation of cloud-based solutions

Validation of cloud-based solutions

E-mails. Sensitive patient data. Dense droplets of water. What’s common between them, you ask? At first glance, absolutely nothing. But let me break it down for you. E-mails are stored in the servers of your e-mail service vendor, which is in turn hosted on the cloud....
Global Data Integrity Guidelines

Global Data Integrity Guidelines

Complying with different regulatory agency guidelines for data integrity can be tricky, given the nuances of each agency in terms of its focus and expectations. Let’s take a quick look at where the three major global regulatory agencies stand with respect to their...
Understanding the MRA

Understanding the MRA

As a compliance consultant, I have always wondered why the same facility or site is inspected by multiple agencies even though the audit reports from the first inspection has demonstrated compliance. After years of contemplation, a big step was achieved last month...
Maintaining Data Integrity during EHR-EDC integrations

Maintaining Data Integrity during EHR-EDC integrations

Integrating Electronic Health Record (EHR) systems with Electronic Data Capture (EDC) systems in clinical trials can save time, effort and cost. However, ensuring data integrity and security during such an integration can be tricky.Here is a simple explainer, breaking...
Healthcare Diary 2019: As It Happened

Healthcare Diary 2019: As It Happened

Healthcare. Technology. Compliance. With technological breakthroughs dominating the headlines, 2019 has seen new trends in the industry. Here’s a look at how the first half of the year has shaped up. June In an attempt to incorporate Real-World Evidence from high-tech...
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