Validation, Commissioning & Design Featured Articles
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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Elevating Quality Beyond Compliance
4/23/2024
See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce.
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EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.
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Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
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Why The FDA General Calibration Requirements Are Not Enough
4/10/2024
Calibration is a niche industry that is not well understood by many. By choosing an ISO 17025-accredited organization, companies can benefit from external auditing and adherence to accepted standards.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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How To Prepare For An Inspection: 8 Tips For Success
3/15/2024
To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.
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Can Today’s ELNs Support Tomorrow’s Labs?
3/14/2024
The global electronic laboratory notebook (ELN) market is growing, however, ELNs must form part of a more comprehensive data strategy and ecosystem or they can impede progress.
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The Write Side Of AI: Helping Hands, Not Replacement Plans
3/1/2024
AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.
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Early Development Considerations For NCE Success: Quality Systems
3/1/2024
Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.