INSIGHTS ON REGULATORY COMPLIANCE
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Tackling Residual DNA Testing In Biotherapy Manufacturing
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
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Navigating The Future Of Lab Developed Tests
Explore the pivotal role of lab-developed tests (LDTs) in medical diagnostics, their growing regulatory scrutiny, and their future trajectory in modern healthcare to advance patient care.
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MSD Global Digital Validation Rollout
See how MSD digitized global validation processes achieved over 50% cycle time reduction, streamlined workflows, improved compliance, and enhanced remote collaboration during COVID-19.
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The High Requirements Placed On Pharmaceutical Labeling Solutions
Regulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.
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Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines8/6/2025
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
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What Is The Position Of Regulatory Authorities On PUPSIT?5/2/2025
PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.
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Electronic Batch Reporting1/22/2024
Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.
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How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs10/24/2024
Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.
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Validation Provider Shortens The Path To Equipment Qualification8/19/2025
Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.
REGULATORY COMPLIANCE SOLUTIONS
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Enhance your chromatographic performance with advanced HPS technology to improve analyte recovery, peak shape, and reproducibility for complex compounds and demanding analytical workflows.
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MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.
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Boost lab productivity and throughput without sacrificing precision with a platform that helps teams work faster and smarter, all within a compact footprint that saves space.
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This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.
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Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.