Validation, Commissioning & Design Featured Articles
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Lost CMC Data In An ALCOA+ World
6/19/2023
As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.
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The 3 Stages Of MES Analytics For Drug Manufacturing
6/14/2023
In order to access all of your organizations manufacturing data and insights, the most practical solution is a cost effective, modern MES for all lines and stages.
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A Practical Look At Data Governance In The Life Sciences
6/13/2023
Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.
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Breeze Through Surprise Audits — Take These 5 Actions Now
6/8/2023
Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
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Smart Batch Processing Is At Your Fingertips
5/30/2023
The data you're collecting may have hidden value that you can uncover using modern manufacturing execution systems. Minimize process deviations with the latest analytics platforms.
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Solving Biopharmaceutical Manufacturing Production Records Challenges
5/30/2023
Solve your companies manual manufacturing production records problems with modern manufacturing execution systems and gain the competitive advantage.
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Live-Cell Imaging Techniques
5/30/2023
Explore how scientists are addressing research questions using live-cell imaging technology that has advanced in recent years to become more versatile and easily accessible.
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Extending Quality Management Through Vendor Compliance Audits
5/25/2023
Explore the primary responsibilities of both manufacturers and vendors during a vendor compliance audit, as well as practical strategies and tools, including audit management software, that make them possible.
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Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing
5/24/2023
During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.
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Set Up A Single Use System For Success
5/22/2023
Utilize a modern distributed control system and single-use systems to meet your organization's regulatory requirements, incorporate newer digital technologies and analytics, and lower the cost of ownership.