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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Germfree’s Compounding Pharmacy equipment and bioGO® Mobile, Modular Pharmacies are Offsite-built, Compounding-ready and available in standard and custom configurations, for sale or lease.
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Applied Biosystems TaqPath assays are the industry-leading choice for probe-based qPCR assays for late-stage pharmaceutical and biotechnology applications. These products offer the reliability and performance of TaqMan Assays while also providing the traceability, documentation, and compliance needed for process development, cGMP manufacturing, and regulatory filings.
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Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 43.5% R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.
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Specialized knowledge and expertise in information technology, quality assurance and laboratory practices is required to successfully implement and maintain laboratory projects and informatics systems within the pharmaceutical, biotech, chemical, food, and environmental industries.
WHITE PAPERS AND CASE STUDIES
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White Paper: The State Of Privacy & Data Security Compliance We are pleased to present The State of Privacy and Data Security Compliance study conducted by Ponemon Institute and sponsored by Sophos. The purpose of the study is to determine if various international, federal and state data security laws improve an organization’s security posture. By Sophos Inc.
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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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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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A Quick Guide To EPCS: What You Need To Know To Implement Electronic Prescriptions For Controlled Substances
Many healthcare providers have delayed implementing electronic prescriptions for controlled substances (EPCS). Some may be waiting for the regulatory dust to settle, as the US Drug Enforcement Agency (DEA) ruling is titled “Interim.” Others may be deterred by the length and complexity of the document.
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The Dog Ate My E-Mail: SOX For The Midsized Enterprise On July 30, 2002, the act of Congress known as Sarbanes-Oxley (SOX) was enacted into law. Since then, boards of directors of midsized enterprises have been scrambling to comply with the act. So how is the midsized enterprise supposed to "keep up" and stay compliant? This white paper will cast some light on the fears of managers and examine several points on SOX compliance that are feasible for the midsized enterprise. Submitted by Xiotech
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Optimize Compliance With Worldwide Document Automation Facing a sales location increase of 273%, Wyndham Vacation Ownership wanted to automate, control and speed the sales contract process to meet the needs of an expanding company and client base and increasing regulatory responsibilities. This case study outlines how the sales team at Wyndham Vacation Ownership gains control, speed, and efficiency with a global contract management solution based primarily on document automation.
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EMV Integration for POS And SaaS-Based Services Providers
Since the EMV liability shift, IT solutions providers have been searching for solutions that are EMV capable, but also help your merchant clients minimize costs and the scope of PCI compliance. So, what are the best options?
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Isn't The RFID Bandwagon Full? The RFID (radio frequency identification) space is a confusing market, and industry experts are not making it any more clear. Used with permission from Integrated Solutions Magazine
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Questions On RFID DoD Compliance There are various technologies and systems in play for complying to the RFID, UID and WAWF mandates. Submitted by Domino ISG
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Keeping Data In Motion: The High Cost Of HIPAA Non-Compliance
In Part 1 of this series, we outlined how HIPAA regulations impact the transfer of protected health data and how those rules apply to fax transmission. In Part 2, we will look at the high cost of noncompliance of HIPAA regulations. According to Rebecca Herold, an expert on information security and privacy, at Rebecca Herold & Associates, LLC, “The Department of Health and Human Services is increasingly aggressive and effective” in enforcing HIPAA regulations.
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Global Survey On Social Media Risks The use of social media in the workplace is growing at a rapid pace. Savvy businesses are using blogs, social networks, video on demand (VoD), wikis and other vehicles to quickly share information with their target audiences. The result can be greater brand awareness and an enhanced image in the marketplace.
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Encapsulon® Assessment Transforms Grocer’s Audit Process
This case study from Wren Solutions discusses the challenges that grocers face including shrink reduction, employee theft, and shoplifting along with managing complex food safety requirements across multiple sections of their stores.
NEWS
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eLogs Plus, A Pioneer In The Field Of Fleet Management Solutions Is Thrilled To Announce eCam Plus In California2/12/2024
eCam Plus, a state-of-the-art dashboard camera system tailored to elevate driver safety and accountability. This latest addition to eLogs comprehensive suite of solutions offers real-time monitoring capabilities, live streaming video, triggered and recorded driver crash alerts, and GPS tracking. For just $39.99/mo includes API Road Dash Cam.
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Cellares Unveils First cGMP Compliant Cell Shuttle In Its South San Francisco Center Of Excellence3/12/2024
Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, today announces the completion of its first current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle.
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Rohde & Schwarz Launches New EMI Test Receiver For Emission Measurements Up To 30 MHz At The EMV 2023 In Stuttgart3/23/2023
Rohde & Schwarz demonstrates the new R&S EPL1000 EMI test receiver for reliable certification measurements with minimum test times at EMV 2023 Stuttgart.
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Alcatraz AI Announces Web-Based Mobile Enrollment And Biometric Privacy Consent Management To Streamline Onboarding And Increase Transparency2/21/2023
Alcatraz AI, a global leader in autonomous access control solutions, today announced the addition of web-based Mobile Enrollment and Privacy Consent Management to its flagship facial authentication product the Rock™.
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Team UiQ Helps Digitise Health And Safety Compliance1/24/2024
In the contemporary workplace, ensuring the health and safety of employees is not just a regulatory obligation but a cornerstone of sustainable business practice.