INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1330782159 stem cell]( "Responding To Fill-Finish And Automation Scale-Up Challenges")
Responding To Fill-Finish And Automation Scale-Up ChallengesBehind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.
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![GettyImages-2024513353 drug manufacturing]( "Selecting The Best Deterministic Method For Your CCIT Project")
Selecting The Best Deterministic Method For Your CCIT ProjectContainer Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.
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![EU GMP Annex 11 Action Plan: Assessment, Strategy And Digital Solutions For Compliance]( "EU GMP Annex 11: Compliance Strategy And Digital Solutions")
EU GMP Annex 11: Compliance Strategy And Digital SolutionsExplore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.
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![Compliance GettyImages-1212446127]( "PUPSIT As Part Of A Contamination Control Strategy (CCS)")
PUPSIT As Part Of A Contamination Control Strategy (CCS)Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.
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Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment11/4/2025
Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.
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AI Implementation To Enhance Quality2/11/2025
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 Requirements12/27/2024
Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.
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How Compounding Pharmacies Are Combating FDA Drug Shortages9/26/2024
Explore the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.
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Overcoming Challenges In Ophthalmic Formulations8/27/2025
Discover key strategies for overcoming formulation challenges in ophthalmic drug development and learn how selecting the right excipients supports quality, compliance, and safety.
REGULATORY COMPLIANCE SOLUTIONS
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![_W5A7012-1]( "Software To Automate And Digitalize Data Recording Steps In QC Workflows")
Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
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![iStock-941351188-lab-cleanroom-sterile]( "Out Of Specification (OOS) Software For Life Sciences")
The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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![mettler toledo safeline x-ray]( "X-Ray Inspection Solutions For The Pharmaceutical Industry")
Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.
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![GettyImages-968924932 Industrial engineers with tablet in a factory checking documents]( "The Industrial DataOps Solution For Industry 4.0")
HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data. The Intelligence Hub enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code. The software is deployed at the Edge to merge real-time, transactional, and time-series data into a single payload for consuming applications.
With the Intelligence Hub, users can speed system integration time, rapidly leverage contextualized data for analytics, AI, and ML applications, and govern data standards across the enterprise. HighByte Intelligence Hub provides the critical data infrastructure for Pharma 4.0.
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![SoftmaxProGxp]( "Meet Regulatory Guidelines In GMP/GLP Labs With SoftMax Pro GxP Software")
Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
