Validation, Commissioning & Design Featured Articles
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
5/12/2023
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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Batch Records Review vs. MES Software
4/27/2023
Learn how more life sciences companies are implementing manufacturing execution systems (MES) to improve quality at every step and get products to patients faster.
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Realizing The Benefits Of CPV With Advanced Analytics
4/26/2023
When implemented correctly using advanced analytics solutions, CPV can provide insights that help companies increase their productivity, reduce costs, and support iterative process improvements.
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Why Collaborative Protocol Design Is Vital To Cell Therapy Trials
4/21/2023
Uncover how autologous cell therapy clinical trial protocol designs can greatly benefit from the inclusion of multifunctional, multi-departmental stakeholders’ input and feedback.
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Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations
4/21/2023
Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
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Are Electronic Manufacturing Logbooks Better Than Paper?
4/10/2023
We accept the aid of automated paperless technology in our everyday lives, so why not in life sciences manufacturing? Check out some of the benefits of eLogbook management.
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Remote Clinical Trial Monitoring: CRA Success In An Era Of Autonomy
4/5/2023
As organizations become more skillful in training and monitoring CRAs, the latter can be empowered with greater flexibility and freedom in scheduling and travel.
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4 Reasons Your Startup Should Implement QMS
3/30/2023
Explore four reasons why your medtech startups is ready to implement quality management system and move into a new digital age.
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4 Digital Transformation Gaps In Pharmaceutical Manufacturing
3/30/2023
Take an in-depth look at the pitfalls of manual, paper-based manufacturing processes and why digitization could be the answer for pharma and medtech manufacturing of the future.