Validation, Commissioning & Design Featured Articles
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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.
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ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments
2/22/2024
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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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.