Featured Articles
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Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance
9/20/2022
QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.
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How Process Digitization Accelerates Northeast Scientific’s FDA Compliance
9/20/2022
Learn how Northeast Scientific digitized and integrated our quality and manufacturing processes to help obtain 510(k) clearance from the FDA for the first and only reprocessed laser atherectomy catheter in the history of reprocessing.
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3 Ways To Improve QMS Documentation: Following International Standards
9/8/2022
We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.
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6 Best Practices For Enterprise Quality Management Solutions Implementation
9/8/2022
While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.
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6 Essential Capabilities Of A Complete eDHR System
8/26/2022
We share tips on how to implement an eDHR system that allows you to capture and leverage all the data needed to optimize production while ensuring compliance with FDA 21 CFR Part 820 requirements.
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Why You Need A Document Management System In Life Sciences
8/25/2022
In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.
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A Guide To Writing Effective SOPs In Life Sciences
8/17/2022
We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.
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8 Tips to Make Computer Software Validation (CSV) Less Painful
7/21/2022
While CSV can be a pain to deal with, it is necessary. Explore our eight best practices that can reduce validation time to a matter of hours or minutes.
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Clarifying Process Verification vs. Process Validation In Med Device
7/13/2022
We answer frequently asked questions to provide background on the intent of the QSR and should shed light on the FDA's perspective of the verification vs. validation conundrum.
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The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance
7/8/2022
Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization.