Compliance
PRODUCTS
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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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An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.
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Bridge regulatory gaps in visual inspection and improve product quality by managing defects throughout the product lifecycle. Get a better understanding of how a centralized data repository can help.
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Eliminate errors and accelerate production with MasterControl MES.
MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.
It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.
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An ultra-compact, and fully configurable, aseptic crimping platform, with capping force measurement, designed to help customers develop and manufacture new drugs and devices at low risk.
WHITE PAPERS AND CASE STUDIES
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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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Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant
Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.
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Virtual Study Yields High Compliance & Retention Rates
Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.
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Mobile-Enabling Logistics: Turning The “Last Mile” Into Aa Competitive Advantage
When it comes to supply chain, the final process of actually delivering the goods can make or break a company. The impact associated with the delivery process affects margins, customer relationships, repeat business, and cash flow. The paper-laden delivery confirmation process often involves capturing key data and customer signatures, and then handing the paperwork to an admin for processing once the drivers are back at the office. This greatly impacts time to invoice, receiving of cash, revenue recognition compliance, and data quality.
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Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements
A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.
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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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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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Continuous Flow — An Emerging Alternative
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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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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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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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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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.
NEWS
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Sentinel Water Solutions And DESOTEC Announce Partnership To Provide NSF-Certified GAC Reactivation Services8/26/2025
Sentinel Water Solutions (Sentinel), a leader in PFAS pilot testing and treatment, today announced an exclusive channel partnership with DESOTEC, one of the world’s leading providers of sustainable activated carbon solutions, to deliver NSF-certified granular activated carbon (GAC) reactivation services for U.S. drinking water utilities.
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Flint Group Confirms German Ink Ordinance Compliance For Sheetfed Packaging Inks And Sheetfed Water-Based Coatings11/18/2025
Flint Group confirms that its Novasens PRIME series of vegetable oil-based Sheetfed Packaging process inks, bases and speciality inks, as well as Novaset water-based coatings, manufactured in Europe, are compliant with the composition requirements of the 21st Regulation amending the German Consumer Goods Regulation, known as the German Printing Ink Regulation (GIO).
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Gnosko Launches RFID-Integrated Chain Of Custody Platform To Help Labs Do More With Less5/20/2025
As laboratories face shrinking research budgets, government funding cuts, and increasing compliance demands, Gnosko is stepping up with a timely solution: a cost-effective, RFID-integrated Chain of Custody (CoC) platform that automates sample tracking, inventory management, and regulatory reporting.
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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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Recipharm Expands Aseptic Filling Capabilities For Process Development, Pilot Scale And Clinical Supply2/5/2025
Recipharm, a leading global contract development and manufacturing organisation (CDMO), has announced that a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany.