Industry Perspectives
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Managing Supply Chain Risks Using Relational Risk Analysis
4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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Best Practices Handling Material Changes For Medical Devices
3/18/2024
Despite the best intentions of procurement, suppliers may impose changes in the availability of material grades. Have a process for controlling and mitigating the effects of material changes in order to reduce risk and avoid interruption.
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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The 10 Most Frequently Asked Questions On Glass: Part 2
2/20/2024
Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.
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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
2/16/2024
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
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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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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3
12/20/2023
This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.