Compliance
PRODUCTS
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FectoVIR®-AAV GMP ticks all the boxes to make each AAV-based gene therapy a success.
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Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward
Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.
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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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BioCentriq has a comprehensive and established quality and compliance function with the personnel, systems, and procedures in place to apply phase-appropriate compliance and a quality-first approach to every program. Both Quality Assurance and Quality Control experts will be involved with your program from the very beginning as an integral part of the team starting with knowledge transfer and culminating with the release of your product.
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The BeamSquared® system is a compact and fully automated tool for measuring the propagation characteristics of CW and pulsed laser systems from the UV to NIR to Telecom wavelengths.
WHITE PAPERS AND CASE STUDIES
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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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Distribution Of The First Commercial CAR-T Therapy From USA To Japan
Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.
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Enterprise Input Management: Feeding Information Lifecycle Management, From Chaos To Control Most information originates outside an enterprise's IT infrastructure and, as such, many companies are seeking new ways to more efficiently manage both the scale and diversity of incoming documents. Just as companies have automated the variety of "output" they manage, they are now seeking solutions that automate the processing of "input." This is the foundation for enterprise input management or EIM. Submitted by Captiva Software
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3 Keys For True HIPAA Compliance
With the HITECH Act giving HIPAA regulatory teeth, hospitals need to be concerned about doctors, nurses and other clinicians communicating about protected health information (PHI) in a non-compliant fashion. A single non-compliant message could lead to a fine of up to $1.5 million.
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Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours
The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.
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Protect Your Health Records And Meet Your Compliance Obligations White Paper: HIPAA And Assureon
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Replacing A Paper-Based GMP System With An Electronic Monitoring System
As a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics' sought to replace an its paper-based GMP record system and manual process with an electronic monitoring system.
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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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Case Study: Electronic Forms Are Nursing Center’s Solution To Electronic Record Submission Requirement When Medicare mandated electronic form submission in order to process patient payments, Ledge View Nursing Center’s manual forms processes became obsolete overnight. A consultant’s electronic forms solution was at the ready, however, to meet the new regulatory requirement without an administrative time savings for nurses allowing more attention to patient care. By FormFast
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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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Integrator Lands A $50,000 UID Installation For A Government Supplier By Matt Angerer, Retail Solutions Online
As a VAR, can you effectively articulate to a potential client the benefits of contracting with you, instead of trying to achieve UID compliance on their own? For A2B Tracking Solutions, continually educating clients on what it means to be UID compliant is the first step. Its second step is providing value-adds in terms of business-to-business data exchange services and compliance-based software upgrades after the initial install. Taking this approach won A2B a recent $50,000 installation with a DoD supplier and is a contributing factor to the VAR’s projected 150% sales growth next year. Used with permission from Business Solutions magazine
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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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Rohde & Schwarz First To Deliver Test Sequences To Fulfill Requirements Of E112 Emergency Caller Location1/24/2022
A new regulation requires all smartphones sold in the European Union from March 2022 onwards to support caller location for 112 emergency calls. To ensure this feature, the devices must be compliant with several positioning systems as outlined by the European Commission.
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Industry-Approved Train-The-Trainer Programs To Certify Mobile Equipment Operators3/31/2023
Train Safe is revolutionizing how businesses provide safety training to their employees.
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PlanSource Partner Marketplace Experiences Meaningful Growth In Q27/26/2022
PlanSource, a leading provider of cloud-based benefits administration technology, announced today that nine additional employer benefits providers have joined the company’s Partner Marketplace — a curated list of best-fit partners designed to maximize HR and broker efficiency, employee engagement and plan participation.
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Rite Aid Corp. Agrees To Develop, Implement Bloodborne Pathogen Safety Program For Retail Employees At All New Jersey, New York Stores8/21/2023
The U.S. Department of Labor today announced an agreement with Rite Aid Corp. to implement a program to better protect employees, including front-end customer service staff, against hazards related to bloodborne pathogens at all its approximately 370 stores in New Jersey and New York.