Insights On Regulatory Compliance
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Cybersecurity And Product Design Of Automated Systems
9/30/2022
Learn about the importance of cybersecurity for automated equipment, it's weaknesses and risks, and how to mitigate for them by sensible practice and good system design.
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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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The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets
3/28/2024
Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.
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How Recent Trends Impact Bringing Your Molecule To Market
7/9/2024
With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
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Correlating Stopper Height To Container Closure Integrity
11/21/2023
Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.
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Getting The CAPA Framework Right The First Time
5/8/2024
CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.
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Remote Regulatory Assessments Q&A
2/20/2024
Explore what Remote Regulatory Assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.
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Single-Use Strategies For Uninterrupted Microbial Monitoring
2/22/2024
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.
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Integrated Annex 1 Compliance
6/5/2023
Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.
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8 Ways Electronic Batch Record Software Boosts Efficiency In Pharmaceutical Manufacturing
3/10/2023
Explore the eight key benefits of EBR Software and what makes this digital manufacturing solution superior to the traditional paper-based approach to managing critical documentation.