Featured Articles
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8 Best Practices For Compliant And Quick Software Validation In The Cloud
7/6/2022
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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A Guide To Digitizing Med Device Manufacturing Operations
7/6/2022
This guide explains what a truly connected, paperless environment looks like while using Manufacturing Excellence.
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Top 5 Pitfalls You Should Know About Medical Device Quality System Auditing
6/24/2022
Learn about the critical questions to ask while planning medical device audit management activities, as well as the five common problem areas with medical device quality system auditing.
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What CDMO's Should Know About Digitization
6/24/2022
Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships.
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The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management
6/22/2022
This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.
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The No. 1 Most Common Problem In FDA GMP Inspections
6/20/2022
With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.
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Steps To Successfully Complete An FDA Inspection
6/20/2022
We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.
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What You Need To Know About ISO 13485 And 21 CFR Part 820
6/10/2022
Here we answer some of the questions commonly asked by companies striving for compliance with ISO 13485 requirements.
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Maintaining Supply Continuity: 3 Ways To Ease Pharma CMO And CDMO Worries
6/6/2022
Learn practical steps that help pharma contract outsourcers exercise greater control over their supplier-related data, interactions, and processes and put them in a better position to cope with supply continuity challenges as they arise.