Compliance
PRODUCTS
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Industry leading pharmacovigilance solutions from clinical development through post-approval.
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A Transfection Solution for Gram-Scale Protein Production
The ExPERT VLx system delivers unmatched transfection scalability with MaxCyte's Flow Electroporation® technology for industry-leading reproducibility, flexibility and ease of use.
- Reduce time, cost and risk
- Transfect up to 200 billion cells, in a single-use system, in less than 30 minutes
- Obtain grams of proteins in weeks, not months
- Achieve reproducible results, superior transfection efficiency, cell viability and protein expression
- Scale seamlessly to expedite your transition from discovery to Phase 1
- Proprietary Flow Electroporation® Technology
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The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.
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Enabling you to design vaccines without reliance on animal sources with our fermentation-produced squalene.
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IntegriCell™ cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. Our state-of-the-art cryopreservation process, integrated with our end-to-end global temperature-controlled supply chain platform, provides unmatched reliability, efficiency, and scope. Our standardized protocols meet the highest compliance standards, ensuring consistent quality and addressing product stability issues associated with fresh donor-derived cellular material for an optimized approach that enhances manufacturing efficiency and streamlines operations.
WHITE PAPERS AND CASE STUDIES
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Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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Operationalizing Disclosure Intelligence For Go-To-Market Success
Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.
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Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control
Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.
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Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Trial
Explore the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.
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Security In The Supply Chain
When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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Nemours Children's Health System Enhances Patient Experience With HID Global EPCS Solution
HID Global Solution Enables DEA-compliant Electronic Prescriptions of Controlled Substances (EPCS)
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A Guide To Pharmaceutical Quality Management
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
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Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
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Developing An Organizational Roadmap For Post Authorization Safety Studies
Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.
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Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Successfully Delivering Critical Stem Cell Samples Across The Globe
To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.
NEWS
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Paylocity Advances One Unified HCM And Finance Platform With Launch Of Integrated Spend Management Solution7/22/2025
Paylocity, a leading provider of cloud-based HR, payroll and spend management solutions, today announced the launch of Paylocity for Finance, a strategic expansion of its modern workforce platform into the Office of the CFO.
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Rohde & Schwarz And U-Blox Validate Module Compliance With The New Chinese GNSS Automotive Specification GB/T2/26/2025
u-blox, a leading global supplier of GNSS modules, and Rohde & Schwarz have successfully validated ublox’s latest automotive GNSS module in accordance with the recently published Chinese GB/T test requirement for automotive on-board GNSS positioning systems using an automated R&S SMBV100B based GNSS simulator solution. This cutting-edge solution will be demonstrated at Mobile World Congress 2025 in Barcelona.
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Miros Sets A New Standard For Real-Time Collaboration With Launch Of Oil Spill Detection Monitoring Application4/2/2025
Designed to run on top of Miros’ trusted OSD system, this solution introduces a new level of real-time visibility, centralized collaboration, and full accountability for offshore operators, setting a new industry benchmark for proactive and transparent oil spill management.
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Anritsu Supports EU Market Expansion By Ensuring Safety And Compliance Of 5G Wireless Devices10/21/2025
Anritsu Corporation has enhanced the functions of its New Radio RF Conformance Test System ME7873NR to support 5G wireless device conformance tests and compliance with the ETSI*1 EN 301 908-25 standard under the European Radio Equipment Directive (RED).
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MangoApps Adds AI-Powered Scheduling & Shift Swap To Its Extensive Workplace Operations App Marketplace7/15/2025
MangoApps today announced powerful new enhancements to its workplace operations platform, introducing AI-powered scheduling and intelligent shift swap capabilities.