July 2016 Posts

Eliminate the Validation Bottleneck

Eliminate the Validation Bottleneck

LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LNS Research.

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ISO 13485:2016: Are you prepared for the transition?

ISO 13485:2016: Are you prepared for the transition?

Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.

Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.
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Identity and Access Management in Quality and Compliance

Identity and Access Management in Quality and Compliance

Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions

Identity and Access Management (IAM) has become a necessary part of enterprise IT and the security infrastructure of an organization. While mostly driven by security concerns, IAM also makes life simpler for the end user of enterprise applications. This is particularly true in today’s world of tight integration between disparate enterprise software and the continuing increase in the adoption of ‘Best of Breed’ SaaS applications. (more…)

Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

It’s an often cited statistic. Inadequate corrective and preventive action (CAPA) processes are still the number one reason for Life Sciences FDA 483s. Every day, the FDA issues three to four CAPA-related citations. If you’re trying to avoid FDA 483s and warning letters, your first step is to develop a CAPA process that is consistent and under control. Let’s explore some ways to make your CAPA process better by teaming up key quality processes and tools for maximum impact. (more…)