Compliance
PRODUCTS
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Ensuring you have equipment that accurately and rapidly assembles syringes and cartridges is crucial to the success of your pharmaceutical manufacturing workflow. The Hull i-Dositecno SY pharmaceutical labeling machine harnesses dual-function robotics for plunger insertion and labeling to ensure the safety and sterility of your product.
- Versatile – ideal for syringes or cartridges in sterile, clean, ready-to-fill (SCF) tubs
- Cleanroom ready
- Fully compliant – 21 CFR Part 11 software and IQ/OQ validation packages available
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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.
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PHCbi brand's 14.7 cu.ft (415L) refrigerator and 6.2 cu.ft (176L) freezer combination unit is designed for temperature performance not commonly found in commercial cabinets. It combines high performance refrigeration control and monitoring systems with energy efficient and cost-effective cabinet design. Separate refrigeration systems and compressors allow you to maintain proper temperature uniformity while saving space for even the smallest of facilities.
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IntegriCell™ cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. Our state-of-the-art cryopreservation process, integrated with our end-to-end global temperature-controlled supply chain platform, provides unmatched reliability, efficiency, and scope. Our standardized protocols meet the highest compliance standards, ensuring consistent quality and addressing product stability issues associated with fresh donor-derived cellular material for an optimized approach that enhances manufacturing efficiency and streamlines operations.
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Planning to launch a patient-centric decentralized clinical trial? Give your clinical trial patients an app that makes it easy to participate—from anywhere at any time.
WHITE PAPERS AND CASE STUDIES
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New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
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An Equitable Way To Meet On-Site Business Needs
Tackling high turnover and employee equity challenges is a priority. Learn how an on-site insourcing solution can provide a stable and motivated team, ensuring project success.
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Developing An Organizational Roadmap For Post Authorization Safety Studies
Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.
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Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine
As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.
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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.
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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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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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Pharma And Biotech: How Labs Achieve Data Integrity
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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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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How Sharp Packaging's Clinical Packaging Process Is 30% Faster
Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.
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Sporting Goods Retailer Takes Safety And Product Testing To A New Level
This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.
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Serialization And Traceability Compliance In Pharma And Med Device
Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.
NEWS
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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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iDox.ai Announces Launch Of iDox.ai Privacy Scout: AI-Powered Solution That Goes Beyond DLP To Protect Sensitive Data In Real Time7/22/2025
iDox.ai, a U.S.-based provider of AI-powered document compliance tools, announces the launch of iDox.ai Privacy Scout, an advanced Data Loss Prevention (DLP) solution engineered to detect and protect sensitive information in real time, particularly in environments deploying Generative AI.
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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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New ServiceTrade Inspections Delivers Unprecedented Efficiency And Revenue Growth Opportunities For Commercial Fire Contractors6/16/2025
ServiceTrade, Inc., the industry-leading provider of field service management solutions that enable commercial service contractors to build stronger, more profitable businesses, today announced ServiceTrade InspectionsTM.
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Thermal Flow Meter Improves Natural Gas Pipeline Booster Station Flare Unit Monitoring8/18/2025
Engineers responsible for natural gas pipeline booster compressor stations will want to learn more about how the ST100A Series Thermal Flow Meter from Fluid Components International (FCI) offers them highly accurate and repeatable gas flow measurement in hazardous areas to assist in compliance with environmental mandates.