Validation, Commissioning & Design Featured Articles
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Get More Insight And Value Out Of Your Electronic Batch Record Data
2/2/2024
Explore a cloud-based alternative to Electronic Batch Record (EBR) software that is well-suited for small to mid-sized biotech or CGT companies.
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Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market
2/2/2024
Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so it continues to meet users’ needs.
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DataOps For Manufacturing: A 4-Stage Maturity Model
1/31/2024
Explore a maturity model that was created to help you better understand where you are on your DataOps journey and where you need to go to achieve the results you expect.
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Need To Improve Your Change Management? Regulators Can Help With That
1/12/2024
The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.
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Using PIMS To Leverage Your MES Data For Process Lifecycle Insights
12/28/2023
Get the most out of your MES data by asking the right questions and preparing for the future of MES in the BioPharma industry.
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State Of Validation
12/20/2023
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey. Find out what the results of this year’s survey concluded.
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Getting CMC Right For Emerging Technologies
12/20/2023
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Early Development Considerations For Late-Stage NCE Success – Part One
12/8/2023
Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.
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ICH Quality Risk Management Guidelines For Biopharma Manufacturing
11/27/2023
Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.
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Your 6 Priority Areas For A Successful 2024
11/27/2023
As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.