Compliance
PRODUCTS
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Industry leading pharmacovigilance solutions from clinical development through post-approval.
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Compliance solutions for product development agility and audit readiness.
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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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Guide operators through dynamic workflows from equipment startup to maintenance.
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Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity
Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.
WHITE PAPERS AND CASE STUDIES
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GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
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Preparing For Post-Market Clinical Follow-Up Under EU MDR
Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.
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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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Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner
In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.
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Analytical Procedure (Method) Lifecycle Management Drives Method Development At Innovative CDMO
A global CDMO proactively adopted MLCM and AQbD methodology to help their customers gain efficiencies, and improve the quality of their drug products, and the adoption of UPLC and PDA/QDa technology has contributed to its success.
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Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
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InnovaGel Gains Quick Return On Investment
InnovaGel, a manufacturer of vitamins and supplements in the nutraceutical and OTC market, was in need of solution for its soft gelatin encapsulation machine application.
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Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
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24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
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Protecting Cardholder Data In The Enterprise Retail Market Merchants are feeling increased pressure from credit card companies to comply with security regulations such as the Payment Card Industry (PCI) Data Security Standard (DSS) and Payment Applications Best Practices (PABP) and are being offered incentives to comply or facing harsh penalties for not complying. Submitted by IP Commerce
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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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Have Confidence In Your Bio/Pharma Data
The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.
NEWS
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ABB Leads In Emissions Monitoring With Industry-First Data Acquisition System Proficiency Test12/5/2024
ABB’s CEM-DAS is the first data acquisition and handling system (DAHS) on the market to successfully pass testing in line with EN 17255, the first international standard for DAHS in emissions monitoring.
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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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Rohde & Schwarz Launches High-Flexibility EMI Test Receivers At EMV2025 Paving The Way For Optimized Investments3/20/2025
The new EMI test receivers R&S EPL1001 up to 1 GHz and R&S EPL1007 up to 7.125 GHz offer engineers a flexible and cost-effective solution for EMI measurements.
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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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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.