Compliance
PRODUCTS
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25 years of Providing World-Class Medical Information Services.
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AES has transformed the landscape of modular cleanroom design, manufacturing and construction. What began as a vision to elevate industry standards has evolved into a legacy of cleanroom solutions that protect the world’s most critical processes.
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The robotic capsule filler, part of the Explore Range, integrates our award-winning Fill2Weight technology, eliminating ‘formulation for filling’ steps and reducing pre-clinical timescales, fast tracking to Phase III.
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PMS is here to help with all your cleanroom contamination needs.
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Did you define your manufacturing contamination control strategy, or is it a collection of changes over time?
WHITE PAPERS AND CASE STUDIES
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Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
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Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.
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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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Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
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Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Focus On Your Core Business Strategy
Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.
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Ensuring On-Time Release Of CAR-T Cell Treatment In Spain
Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.
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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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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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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.
NEWS
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Nu-Tek BioSciences Reinforces Global Supply Leadership With Halal Certification Renewal2/25/2026
Nu-Tek BioSciences, the industry leader in 100% animal-origin-free (AOF) peptones and yeast extracts, announced today that it has successfully renewed its Halal certification from The Islamic Food and Nutrition Council of America (IFANCA).
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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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New GARDCO RTM Digital Micrometer7/1/2025
Paul N. Gardner USA (GARDCO) – worldwide distributors, producers, and designers of quality physical and inspection instruments for the paint, coatings, and related industries–announces its new offering the new RTM Digital Micrometer with the comprehensive RT Kit option.
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AERZEN Launches New BABA-Compliant Blowers6/6/2025
Aerzen USA is excited to announce the launch of its new Build America, Buy America (BABA) compliant blowers and controls. These blowers and controls are designed to meet the requirements of the BABA Act and support domestic manufacturing jobs.