Compliance
PRODUCTS
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Revolutionizing Global mRNA Production: Germfree's Innovative Cleanrooms Drive Manufacturing Success
Cleanroom requirements for mRNA manufacturing encompass stringent particle control, temperature and humidity management, solvent management and robust contamination prevention strategies. Germfree’s advanced cleanroom solutions address these challenges, ensuring seamless equipment integration, process adaptability, and compliance with regulatory standards. Their tailored mobile and modular facilities support the emerging trend for localized vaccine production, empowering biopharmaceutical companies to harness the transformative potential of mRNA technology in a rapidly advancing field, and ultimately contributing to global immunization efforts.
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Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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Change how you compete by getting the clinical data services and support you need. Medrio is here to help clinical trial sponsors and CROs build internal expertise and support any clinical trial data management needs.
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In the biopharma industry, time-to-market matters for you, your stakeholders, and consumers. Thermo Fisher Scientific helps expedite biologics development with our complete qPCR ecosystem.
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Streamline data, maximize efficiencies, tighten up costs, and reach end goals faster using Medrio’s powerful and intuitive EDC tool.
WHITE PAPERS AND CASE STUDIES
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FoodTronix/PathwayLINK Case Study FoodTronix is a Dallas, Texas-based provider of "economical yet secure" POS solutions and a suite of technology products to restaurant market.
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Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine
As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.
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Pharma And Biotech: How Labs Achieve Data Integrity
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM
Explore how a U.S. biotech company uses RAM to centralize maintenance, calibration, and validation to improve compliance, efficiency, and visibility across multiple facilities.
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Cabrini Health Experiences Improved Operational Efficiency And Other Significant Benefits With triCerat
Cabrini Health is a not-for-profit Catholic healthcare service with 3,800 employees and over 700 beds comprising of two acute care hospitals, a palliative care service, rehabilitation hospital, residential care facility, and pharmacy department.
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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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Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
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A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
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Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Case Study: Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
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Serialization And Traceability Compliance In Pharma And Med Device
Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.
NEWS
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airSlate SignNow And Paperwise Partner To Redefine eSignature And Workflow Automation3/10/2025
airSlate, a global leader in electronic signature and document workflow automation, is excited to announce a new integration and reseller partnership with Paperwise, a premier provider of process automation and document management solutions.
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AppTec360's Advanced Mobile Content Management Solutions Reinforce Enterprise Security3/11/2025
Data security remains a critical concern for organizations as the risk of breaches and unauthorized information sharing continues to rise. Addressing these challenges, AppTec360 introduces ContentBox, a Mobile Content Management (MCM) solution designed to enhance security while enabling seamless file synchronization and controlled data access.
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Selkirk Pharma Announces New APS Qualified Facility With Advanced Fill/Finish Capacity In Spokane, WA2/15/2024
Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity.
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AERZEN Launches New BABA-Compliant Blowers6/6/2025
Aerzen USA is excited to announce the launch of its new Build America, Buy America (BABA) compliant blowers and controls. These blowers and controls are designed to meet the requirements of the BABA Act and support domestic manufacturing jobs.
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RemotePass Simplifies HR And Payroll For UAE Companies With New Direct Employee Feature6/5/2024
Leveraging its experience as a global platform offering contractor management and employer-of-record services in 150 countries, RemotePass, an HR and fintech platform, has launched 'Direct Employee.'