Featured Articles
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5 Answers To FDA Computer System Validation Questions
4/8/2022
We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.
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5 Priorities For Manufacturing Software
4/6/2022
Learn where modern manufacturing execution software can, and should, provide the essential functionality needed to address pharmaceutical and medical device manufacturers’ pressing production needs.
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Pharma Supply Chains Call For Better Visibility
4/6/2022
Product shortages — particularly pharmaceuticals — have imposed the heaviest toll on society. We outline recommendations for improving your pharma supply chain operations.
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FDA Remote “Inspections” During The Pandemic
3/24/2022
Remote inspections can be easy if the company being audited has invested in a quality management system that stores its documents, provides version control, and tracks all changes.
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Clarifying Confusion In Quality Assurance, Control, And Management Systems
3/24/2022
With similar-sounding terminologies, it’s easy to misinterpret their definitions and purposes. Here we demystify the roles of each quality function, ways they differ, and impact on one another.
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How A Robust Manufacturing Software Solution Can Reduce The Frequency And Impact Of Deviations
3/22/2022
Read how to leverage manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse.
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20 Years Later, 21 CFR Part 11 Is More Relevant Than Ever
3/11/2022
With the evolution of technology, 21 CFR Part 11 is more applicable than ever due to the increased use of digital technology for these quality management tasks.
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7 Key Concepts In The FDA’s Quality System Guidance For Pharma
3/4/2022
Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.
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3 Reasons Life Sciences Should Adopt A Data-Centric Quality Mindset
2/16/2022
So few are poised to adopt a data-centric approach by using digitization, analytics, and AI that those who do will reap benefits from the data in their now unstructured documents.
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Modern Manufacturing: The Investment in Digitization Costs Less Than Falling Behind
2/1/2022
By adopting digital solutions today, manufacturers can capitalize on the opportunities of modern manufacturing solutions and realize their full potential.