Compliance
PRODUCTS
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Enable co-location of cell culture media and buffer manufacturing and bioproduction with Krakatoa K500, the first bioreactor-scale pod-based manufacturing system. Produce up to 500 liters of sterile solutions on-demand in less than 3 hours.
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PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model
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Identify & engage healthcare professionals (HCP) treating eligible patients—in near real-time
Timely physician engagement is critical to therapy adoption. Quest Diagnostics combines near real-time lab data with other data sources including EHR, claims and prescription data to help pharmaceutical teams identify and connect with physicians managing eligible patients at key decision time point in the patient journey.
In today’s competitive pharmaceutical landscape, ensuring that physicians receive timely, relevant information about new therapies is essential. Quest’s unique combination of industry-leading deidentified lab data, enhanced with claims, prescription (Rx), and EHR insights, allows pharma teams to refine targeting, optimize engagement, and drive better patient outcomes.
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Pharmaceutical labeling and kitting are critical for ensuring drug safety, compliance, and efficiency. Explore advanced technology and regulatory adherence to streamline these processes.
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Capture data at the true source: the patient. Improve the patient experience with secure, accessible questionnaires both via email and through the Castor Connect mobile application.
WHITE PAPERS AND CASE STUDIES
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control
Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.
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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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X-Ray Inspection For Supplement Safety
Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.
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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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Advancing Compliance And Digital Strategy To Align With Pharma 4.0
AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.
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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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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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Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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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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Secure Storage: A Necessary Evolution All large organizations have gone to great lengths to protect their information assets. All kinds of security systems, from network firewalls and VPNs to passwords and physical mechanisms have been implemented to prevent unauthorized access to networks and premises. Submitted by Nexsan Technologies, Inc.
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Overcoming Obstacles To Deliver Critical Autologous Cell Therapy
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
NEWS
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Asimily Achieves SOC 2 Type II Certification And C5 Attestation, Strengthening Global Compliance Leadership In IoT And OT Risk Management8/14/2025
Asimily, the only complete IoT, OT, and IoMT risk mitigation platform, today announced it has achieved both SOC 2 Type II certification and C5 attestation, two globally recognized benchmarks for security, privacy, and operational excellence.
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SignWell Launches NOM-151 Compliant E-Signatures In Mexico12/9/2025
Businesses across Mexico now have a more straightforward, more affordable way to sign documents online legally. SignWell, a leading e-signature platform trusted by over 65,000 businesses globally, is now officially offering NOM-151-compliant electronic signatures, ensuring legal validity under Mexican regulations.
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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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Swiftly And Circle K Launch Nation's Largest Convenience Retail Alcohol Cashback Program, Opening A New Path To Digital Growth7/10/2025
Swiftly, a leading provider of innovative retail technology tools and solutions, today announced the rollout of the largest alcohol cashback program in U.S. convenience retail, in partnership with Circle K, a global leader in convenience and mobility.
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SwiftComply Launches Next-Gen Pretreatment Module, Setting A New Standard For Water Compliance6/18/2025
SwiftComply, the software platform built specifically for water utility compliance, today announced the launch of its new Pretreatment module, a specialized, smart system for managing industrial wastewater oversight.