Compliance
PRODUCTS
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Viral vector manufacturing: key to successful gene therapy
Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.
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Help your patients make informed decisions without burying them in paper
With electronic informed consent (eConsent) software, your patients can access consent forms using any device they choose. And because it’s part of TrialKit’s unified platform, both your patients and your study team get a seamless experience.
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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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For more than 20 years, Eurofins PSS Insourcing Solutions® has partnered with biotech and pharmaceutical companies to successfully validate and open new or remodeled facilities, meeting regulatory requirements. With a proven track record across numerous facility projects, our flexible, client-focused model ensures seamless integration with internal teams and third-party vendors, delivering high satisfaction and long-term partnerships.
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Eurofins PSS Insourcing Solutions delivers comprehensive manufacturing support that meets production goals with precision, compliance, and agility for biotech, pharmaceutical, and CDMO organizations. Our insourcing model places fully trained, managed scientific teams directly at client sites, enabling seamless integration into manufacturing operations while maintaining flexibility and long-term stability.
WHITE PAPERS AND CASE STUDIES
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Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
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AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
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Ensuring Compliance With Part 11: A Site's Perspective
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.
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Maximize Output From Full-Time Employees
Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.
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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.
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A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System
CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
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Managing Hospitality And Entertainment Spending The ability for hospitality and entertainment enterprises to effectively source, procure, and manage their spend must keep pace with the demand for promptness and compliance in supplier relationship management (SRM). Submitted by Epicor Software Corporation
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Intelligent Workflow From Farm To Processing At Dobler & Sons
Dobler & Sons has incorporated a fleet management system to comply with the recent ELD mandate and to improve overall efficiency in managing it’s fleet and team of drivers.
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Aligning Competing Interests While Optimizing The Service Chain In The Transportation Sector
This paper explores convergence in detail, starting with a breakdown of the service chain into its key components. We then discuss the obstacles and inherent consequences of inadequate efforts in each of these areas before presenting a model that helps set transportation companies up for success in service chain optimization.
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How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
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Liquid Handling Solutions For Bulk Drug Substance Management
How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.
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Support Manufacturing Operations With Process Data Management Software
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
NEWS
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Evonik Coating Additives Launches First Mass Balanced Products For Coatings And Inks3/12/2025
Evonik Coating Additives introduces its first two mass balanced products, TEGO Wet 270 eCO and TEGO Foamex 812 eCO, providing coating and ink formulators with the same high-performing defoamer and wetting agent properties they expect, but with a reduced carbon footprint.
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iDox.ai Announces Launch Of iDox.ai Privacy Scout: AI-Powered Solution That Goes Beyond DLP To Protect Sensitive Data In Real Time7/22/2025
iDox.ai, a U.S.-based provider of AI-powered document compliance tools, announces the launch of iDox.ai Privacy Scout, an advanced Data Loss Prevention (DLP) solution engineered to detect and protect sensitive information in real time, particularly in environments deploying Generative AI.
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KPA Flex Software Enhances Construction Safety And Compliance With Advanced Features5/6/2024
KPA, a leading provider of Environment, Health, and Safety (EHS) compliance solutions, announced the release of new features in the KPA Flex software platform that are specifically tailored for construction safety programs to streamline efficiency, increase real-time visibility, and foster a robust safety culture.
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Rise Expands Employer Of Record Services To Revolutionize Global Hiring And Payroll Compliance4/3/2025
Rise, the pioneering Web3-enabled payroll and compliance platform, has announced the expansion of its Employer of Record (EOR) services, enabling businesses to seamlessly hire full-time employees across borders without the need to establish local entities.
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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.