Compliance
PRODUCTS
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Ideal for biotherapeutic protein production in suspension CHO cells, the CHOgro expression medium is a chemically defined, hydrolysate-free and animal-origin-free medium.
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Meet FDA guidelines for GMP in tablet and capsule production with a secure, failsafe system. Qualification reports are available.
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PHCbi brand’s 23.7 cu.ft (671 L) upright pharmaceutical refrigerator offers a high-capacity solution for clinical and biomedical storage. Five pull-out drawers provide organized access, while fan-forced air circulation help helps ensures uniform temperature control from 2°C to 23°C. A microprocessor system with alarms helps maintain stability and safety. The shelves can be arranged to accommodate different configurations. The unit is deep and strong enough to hold processing equipment and most devices. It offers optimal performance without compromising efficiency.
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Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.
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Expedite your development with our comprehensive suite of GMP services specifically designed to streamline regulatory and get you to market faster.
WHITE PAPERS AND CASE STUDIES
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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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AIIM 2004: In Comes Compliance, Out Goes The Cash As he made the rounds at AIIM Expo 2004, Chief Editor Tom von Gunden found vendors offering — and end users ready to buy — ECM, BPM, and ILM solutions targeting compliance-driven needs.
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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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How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency
With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.
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A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
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Electronic Informed Consent: Considerations For Implementation In Clinical Trials
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
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Improving Global Labeling Workflow
One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.
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Strategic Hiring For Scalable Success
Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.
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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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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
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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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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.
NEWS
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New Automated Cybersecurity Testing For Embedded Software Available In Compliance With RED EN18031 Standard7/23/2025
Starting in August of this year, connected digital products will be required to comply with the EU Directive RED (Radio Equipment Directive) EN 18031. In response, Düsseldorf-based cybersecurity company ONEKEY has integrated testing for RED EN 18031-1 into its automated cybersecurity platform.
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MangoApps Adds AI-Powered Scheduling & Shift Swap To Its Extensive Workplace Operations App Marketplace7/15/2025
MangoApps today announced powerful new enhancements to its workplace operations platform, introducing AI-powered scheduling and intelligent shift swap capabilities.
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Zipline Announces UKG Partnership Enhancement6/17/2025
Zipline, the leading platform for frontline execution and communication, today announced a major enhancement to its UKG integration. With this release, frontline employees can now confirm key compliance-related details directly in Zipline during clock-in and clock-out, with the information syncing seamlessly to UKG’s existing attestation workflows.
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Traliant Unveils New And Redesigned Workplace Violence Prevention Training To Strengthen Employee Safety And Compliance11/20/2025
Traliant, an innovator in online compliance training solutions, today announced the launch of its new and redesigned Workplace Violence Prevention courses.
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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.