INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1820641538 pills, health]( "A Complete Guide To Capsule Checkweighing")
A Complete Guide To Capsule CheckweighingUnderstand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.
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![GettyImages-1464561980 Quantum Computing]( "Lessons Learned From Implementing FDA CSA Guidance")
Lessons Learned From Implementing FDA CSA GuidanceExplore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.
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![GettyImages-1370928101 regulatory compliance]( "Annex 21 – Are We On Track And Is There An Impact?")
Annex 21 – Are We On Track And Is There An Impact?What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply?
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![GettyImages-1391164235 eye disease]( "Achieving Ophthalmic Production")
Achieving Ophthalmic ProductionA partner with state-of-the-art facilities can guarantee efficient and scalable production of ophthalmic solutions, drops, and ointments, and is critical as you navigate the complexities of ophthalmic production.
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Analytical Approaches For Quantifying Residual Host Cell DNA5/29/2025
In this webinar, we’ll discuss the challenges, risks and considerations involved in developing and using in-house residual testing solutions, and the benefits of using commercial kits for residual DNA testing.
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Avoiding The Pitfalls Of PQR10/9/2024
Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."
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Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence7/7/2025
JHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.
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MilliporeSigma's 97-Day Implementation Success Story3/19/2025
Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.
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ISO Cleanroom Standards6/24/2025
Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.
REGULATORY COMPLIANCE SOLUTIONS
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![Thermo Testing System]( "Rapid Sterility Testing: Actionable Results In Less Than 5 Hours")
Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.
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![Scientist laboratory ipad iStock-1207515232]( "FDA 21 CFR Part 11-Compliant Software")
Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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![Class 2 Biological Safety Cabinet Type A2]( "Class 2 Biological Safety Cabinet")
The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.
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![CRISPR]( "Cleanrooms And Equipment For CRISPR Drug Manufacturing")
Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward
Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.
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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.
